1 фаза Клинические исследования при цитомегаловирусной инфекции, взрослые и пожилые (66+)


RankStatusStudy
1Not yet recruitingAutologous Cytomegalovirus (CMV) Specific CD8+ T Cells as Treatment for CMV Reactivation
Conditions:CMV Reactivation;   Allogeneic Stem Cell Transplantation;   Autologous CMV Specific CD8+ T Cells
Interventions:Procedure: Lymphopheresis;   Procedure: CMV specific lymphocyte infusion;   Procedure: Peripheral blood for CMV DNA PCR;   Procedure: Haematology/Blood chemistry
Sponsor:Imperial College London
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:25
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01326273
Other IDs:JROHH0202
First Received Date:March 22, 2011
Start Date:June 2011
Completion Date:June 2014
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:June 2014
Outcome Measures:Response to adoptive transfer of autologous CMV-specific CD8+ T-cells;   The occurrence of subsequent CMV reactivations;   Rate of complete response;   Rate of early complete response;   Rate of subsequent CMV reactivation
2Unknown CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease
Condition:Allogeneic Stem Cell Transplantation
Intervention:Biological: CMV pp65 Specific T Cells
Sponsors:Duke University;   National Institutes of Health (NIH);   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other / NIH
Study Type:Interventional
Study Design:Intervention Model: Single Group Assignment;   Masking: Open Label
NCT ID:NCT00611637
Other IDs:4138-07-10R5,   IND 11649
First Received Date:January 29, 2008
Start Date:August 2005
Completion Date:
Last Updated Date:February 8, 2008
Last Verified Date:January 2008
Acronym:CMV-BMT
Primary Completion Date:February 2010
Outcome Measures:Number of CMV pp65 specific CD8+ T cells produced.;   Development of grade III-IV GVHD or major organ toxicity.;   Presence of CMV in peripheral blood.;   Percentage of CD8+ T cells that are CMV pp65 specific.
3RecruitingTrial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Biological: CMV-Peptide-Specific T cells
Sponsor:Memorial Sloan-Kettering Cancer Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00674648
Other IDs:05-065
First Received Date:May 6, 2008
Start Date:August 2007
Completion Date:August 2011
Last Updated Date:November 2, 2010
Last Verified Date:November 2010
Acronym:
Primary Completion Date:August 2011
Outcome Measures:To assess the safety or toxicities of escalating doses of donor-derived CMV-pp65 peptide-specific T cells.;   To quantitate alterations in the level of CMV antigenemia in the blood of patients with either active infection or persistent antigenemia following adoptive transfer of CMV-pp65 peptide-specific T cells.
4RecruitingEvaluation of Recovery From Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer
Conditions:Glioblastoma;   Cytomegalovirus
Interventions:Biological: CMV-ALT + CMV-DCs;   Biological: CMV-ALT + Saline
Sponsor:Duke University
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:12
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
NCT ID:NCT00693095
Other IDs:PRO00000580,   SPORE Project 3
First Received Date:June 3, 2008
Start Date:September 2008
Completion Date:December 2016
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:ERaDICATe
Primary Completion Date:June 2016
Outcome Measures:To evaluate if vaccinating adult patients with newly-diagnosed GBMs using CMV-DCs during recovery from therapeutic TMZ-induced lymphopenia with ALT in patients that are seropositive for CMV enhances the T-cell response.;   To evaluate the safety of ALT with CMV pp65-activated T-cells in adult patients with newly-diagnosed GBMs during recovery from therapeutic TMZ-induced lymphopenia.
5RecruitingAdministration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme
Conditions:Glioblastoma Multiforme;   Brain Cancer
Intervention:Biological: CMV-specific CTL
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine;   The Methodist Hospital System
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01205334
Other IDs:26901-COGLI
First Received Date:September 17, 2010
Start Date:November 2010
Completion Date:November 2020
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:COGLI
Primary Completion Date:November 2020
Outcome Measures:Primary: To evaluate the safety and persistence of escalating doses of autologous CMV-specific cytotoxic T-lymphocytes (CTL) in patients with CMV-positive Glioblastoma multiforme (GBM);   Secondary Objectives: To evaluate the effects of CMV-specific CTL on measurable disease.;   To measure the survival and function of CMV-specific CTL in vivo.
6Unknown Adoptive Immunotherapy for CMV Disease
Condition:CMV Disease
Intervention:Biological: CMV vaccine
Sponsor:Hadassah Medical Organization
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00159055
Other IDs:280303-HMO-CTIL
First Received Date:September 9, 2005
Start Date:February 2004
Completion Date:
Last Updated Date:December 12, 2005
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measures:Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.;   Evaluate toxicity of the procedure.
7Not yet recruitingTrial of CMV Specific DLIs From 3-6/6 HLA Matched Family Member Following Nonmyeloablative Allo SCT
Condition:Cytomegalovirus Infections
Intervention:Biological: CMV Specific T Cell donor lymphocyte infusion
Sponsor:Duke University
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:32
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01274377
Other IDs:00013947
First Received Date:January 9, 2011
Start Date:February 2011
Completion Date:February 2018
Last Updated Date:January 20, 2011
Last Verified Date:January 2011
Acronym:
Primary Completion Date:February 2016
Outcome Measures:Safety of CMV Specific T cell infusion following Stem Cell Transplant;   Efficacy of CMV-specific T cell infusion in terms of response, progression free survival, and overall survival;   Evaluate the recovery of immune function post engraftment with this regimen.
8RecruitingSafety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus
Conditions:Cytomegalovirus Infection;   Adenovirus Infection
Intervention:Biological: Dose Escalation Comparison
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00880789
Other IDs:23668-ACT CAT
First Received Date:April 13, 2009
Start Date:May 2009
Completion Date:May 2015
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:ACT-CAT
Primary Completion Date:May 2014
Outcome Measures:To determine safety, toxicity and MTD of one intravenous injection of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV and Adenovirus given to patients with or at risk for CMV and adenovirus disease after cord blood transplant;   To evaluate the feasibility of generating a sufficient number of umbilical cord blood-derived cytotoxic T lymphocytes (CTLs) specific for CMV and Adenovirus;   To evaluate the impact of these CTLs on Adenovirus-specific T-lymphocyte immune reconstitution.;   To evaluate the recovery of virus-specific immunity after CTL infusion and its correlation with viral clearance and/or protection from viral infection/disease.
9RecruitingStudy of Administration of CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM
Condition:Brain Cancer
Intervention:Drug: HER.CAR CMV-specific CTL
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01109095
Other IDs:H-24487 - HERT GBM
First Received Date:April 13, 2010
Start Date:October 2010
Completion Date:October 2031
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:HERT-GBM
Primary Completion Date:October 2016
Outcome Measures:Evaluating the safety and persistence of escalating doses CTL;   Evaluating and Measuring the effects of gene modified CTL
10RecruitingCytotoxic T-Lymphocytes for the Prophylaxis of Cytomegalovirus After Allogeneic Stem Cell Transplant
Conditions:Stem Cell Transplantation;   Cytomegalovirus Infections
Intervention:Biological: CMV CTL infusion
Sponsors:Baylor College of Medicine;   The Methodist Hospital System;   Texas Children's Hospital;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:40
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00078533
Other IDs:12683-VICTA,   VICTA
First Received Date:March 1, 2004
Start Date:April 2004
Completion Date:December 2021
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:VICTA
Primary Completion Date:December 2021
Outcome Measures:safety, toxicity and maximum tolerated dose (MTD);   Efficacy of recovery of virus-specific immunity and correlation with protection from viral reactivation/disease.
11CompletedA Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)
Condition:Cytomegalovirus Infections
Interventions:Biological: AVX601;   Biological: Placebo
Sponsor:AlphaVax, Inc.
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:40
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
NCT ID:NCT00439803
Other IDs:AVX601-001
First Received Date:February 23, 2007
Start Date:April 2007
Completion Date:July 2008
Last Updated Date:November 7, 2008
Last Verified Date:November 2008
Acronym:CMV
Primary Completion Date:July 2008
Outcome Measures:evaluate safety of AVX601 based on teh frequency of Grade 2,3,or 4 systemic reactogenicity events;   evaluate the immunogenicity of AVX601 in healthy volunteers after 3 doses of vaccine
12CompletedCytomegalovirus (CMV) Specific Cytotoxic T Lymphocytes (CTL) When Used for Prophylaxis Against CMV in Recipients of Allogeneic, T Cell Depleted Stem Cell Transplants
Condition:Cytomegalovirus Infections
Intervention:Other: CMV Specific Cytotoxic T Lymphocytes
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:47
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00673868
Other IDs:26769
First Received Date:May 1, 2008
Start Date:October 2007
Completion Date:
Last Updated Date:January 22, 2009
Last Verified Date:April 2008
Acronym:
Primary Completion Date:
Outcome Measures:The primary objective is to characterize CMV specific immunity in subjects receiving and in those randomized to not receive CMV CTL. We will characterize CMV CTLp frequencies and bulk cytotoxicity at days 30 and 60 post infusion.;   To characterize the time to develop CMV specific immunity in pts. receiving and not receiving CTL by assessing CMV CTL;   To determine the CMV epitopes recognized by donors;   To characterize the levels of CMV DNA in recipients of CMV CTL and non CTL
13CompletedTrial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
Condition:Cytomegalovirus Infection
Interventions:Biological: VCL CT02 pDNA vaccine;   Biological: Towne CMV vaccine
Sponsors:University of California, San Francisco;   Vical
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:16
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00373412
Other IDs:Jacobson VCL CT-02 TC
First Received Date:September 6, 2006
Start Date:October 2006
Completion Date:
Last Updated Date:May 5, 2008
Last Verified Date:October 2006
Acronym:
Primary Completion Date:February 2008
Outcome Measures:CMV-specific immune response post-Towne challenge: gB antibody, T-cell IFN-g ELISPOT, T-cell proliferation assays for IE1, pp65, and/or gB, cytokine and phenotypic flow cytometry responses to pp65, IE1, gB.;   Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).
14CompletedPhase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM
Condition:Cytomegalovirus Infection
Intervention:Biological: Towne CMV vaccine
Sponsors:University of California, San Francisco;   Vical
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:10
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00370006
Other IDs:Jacobson VCL CT-02 IDTC
First Received Date:August 28, 2006
Start Date:September 2006
Completion Date:August 2007
Last Updated Date:January 10, 2007
Last Verified Date:October 2006
Acronym:
Primary Completion Date:
Outcome Measures:CMV-specific immune response post-Towne challenge: gB antibody, T-cell IFN-g ELISPOT, T-cell proliferation assays for IE1, pp65, and/or gB, cytokine and phenotypic flow cytometry responses to pp65, IE1, gB.;   Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).
15CompletedStudy to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-Seronegative Healthy Male Adult Subjects
Condition:Cytomegalovirus
Intervention:Biological: GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A
Sponsor:GlaxoSmithKline
Gender:Male
Group:Adult
Phase:Phase I
Number Enrolled:40
Funded By:Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00435396
Other IDs:108890,   109211
First Received Date:February 14, 2007
Start Date:February 2007
Completion Date:
Last Updated Date:October 27, 2008
Last Verified Date:October 2008
Acronym:
Primary Completion Date:August 2008
Outcome Measures:Occurrence, intensity and relationship to vaccination of solicited local and general AEs.;   Occurrence, intensity and relationship to vaccination of unsolicited AEs.;   Occurrence and relationship to vaccination of any SAEs.;   Haematological and biochemical parameters.;   Anti-gB antibody avidity in all groups;;   Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups;   Anti-CMV tegument proteins antibody response in all groups;;   Frequencies of CD4/CD8 T-cells with antigen-specific IFN-g, IL-2, TNF-a and/or CD40L secretion/expression to gB as determined by ICS in all groups;;   Anti-Herpes simplex virus (HSV) gD antibody response in all groups.;   Anti-glycoprotein B (gB) antibody concentrations in all groups;;   Anti-CMV Western Blot in all groups.
16TerminatedA Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
Condition:Glioblastoma Multiforme
Interventions:Drug: Fludarabine;   Drug: Cyclophosphamide;   Biological: CMV Specific Cytotoxic T Lymphocytes (CTL)
Sponsor:Penn State University
Gender:Both
Age Groups:Child / Adult
Phases:Phase I / Phase II
Number Enrolled:10
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00990496
Other IDs:31717,   PSHCI #09-045
First Received Date:October 5, 2009
Start Date:September 2009
Completion Date:September 2011
Last Updated Date:October 19, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:September 2011
Outcome Measures:To determine the incidence of tumor responses, as defined as stable disease, partial, or complete responses after the infusion of CMV CTL.;   To determine the duration and magnitude of donor chimerism post infusion by micro chimerism assays.;   To determine the incidence of increases in CMV pp65 or IE-1 T cells post infusion of allogeneic CMV CTL of GBM patients.;   To determine safety of allogeneic CTL infusions in this patient population.
17RecruitingInjection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
Conditions:Cytomegalovirus Infections;   Adenovirus Infections
Intervention:Other: Cell therapy
Sponsor:Assistance Publique - Hôpitaux de Paris
Gender:Both
Age Groups:Child / Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:30
Funded By:Other
Study Type:Interventional
Study Design:Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT01325636
Other IDs:P090801
First Received Date:March 28, 2011
Start Date:March 2010
Completion Date:September 2012
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:CTLantiCMV
Primary Completion Date:September 2012
Outcome Measures:CMV blood viral load by PCR;   GvHa evaluation;   Evaluation of clinical signs according to interested organs (lung, liver, bowel,…);   Increase of T cells
18CompletedThe Safety and Effectiveness of Different Dose Levels of 1263W94 in the Treatment of Cytomegalovirus (CMV) of the Eyes in HIV-Infected Patients
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Maribavir
Sponsor:Glaxo Wellcome
Gender:Male
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:56
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00002373
Other IDs:263A,   CMAA1003
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:November 1998
Acronym:
Primary Completion Date:
Outcome Measure:
19CompletedA Trial to Study How the Body Fights Off Cytomegalovirus (CMV) in Hematopoietic Transplant Recipients.
Condition:Cytomegalovirus Infection
Intervention:
Sponsor:Mayo Clinic
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:50
Funded By:Other
Study Type:Observational
Study Design:Observational Model: Defined Population;   Observational Model: Natural History;   Time Perspective: Longitudinal;   Time Perspective: Prospective
NCT ID:NCT00273143
Other IDs:1052-05
First Received Date:January 6, 2006
Start Date:May 2005
Completion Date:
Last Updated Date:January 6, 2006
Last Verified Date:January 2006
Acronym:
Primary Completion Date:
Outcome Measure:
20RecruitingSafety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
Condition:Cytomegalovirus
Intervention:Biological: cmv vaccine
Sponsors:Virginia Commonwealth University;   International AIDS Vaccine Initiative
Gender:Male
Group:Adult
Phase:Phase I
Number Enrolled:36
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT01195571
Other IDs:1
First Received Date:September 2, 2010
Start Date:September 2010
Completion Date:March 2012
Last Updated Date:November 10, 2010
Last Verified Date:September 2010
Acronym:
Primary Completion Date:March 2012
Outcome Measure:Safety

RankStatusStudy
21TerminatedA Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.
Conditions:Encephalopathy;   HIV Infections;   Radiculitis
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
NCT ID:NCT00000856
Other IDs:ACTG 305
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:March 2004
Acronym:
Primary Completion Date:
Outcome Measure:
22CompletedA Phase I/II Trial to Assess the Safety and Tolerance of Escalating Doses of a Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Sevirumab
Sponsor:Sandoz Inc.
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002016
Other IDs:071B,   Study No B103
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:April 1993
Acronym:
Primary Completion Date:
Outcome Measure:
23RecruitingMost Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)
Conditions:Adenovirus Infection;   EBV Infection
Intervention:Biological: Most Closely Matched CTLs with Adenovirus
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Brigham and Women's Hospital;   Massachusetts General Hospital;   M.D. Anderson Cancer Center;   National Marrow Donor Program;   The EMMES Corporation;   Duke University;   Beth Israel Deaconess Medical Center;   Children's Hospital Los Angeles;   National Heart, Lung, and Blood Institute (NHLBI);   Children's Hospital Boston;   University of Miami;   Hackensack University Medical Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:45
Funded By:Other / Industry / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00711035
Other IDs:22994-CHALLAH,   CHALLAH
First Received Date:June 20, 2008
Start Date:November 2008
Completion Date:July 2012
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:CHALLAH
Primary Completion Date:July 2010
Outcome Measure:The primary purpose of the study is to assess the safety of administering CHM-CTLs in transplant patients with EBV, CMV, or adenovirus infection. We have elected to use a dose of 2 x 107 CHM-CTLs/m2.
24CompletedA Randomized, Phase I/II Trial to Assess the Safety and Antiviral Effects of Escalating Doses of A Human Anti-Cytomegalovirus Monoclonal Antibody (SDZ MSL-109) in Patients With the Acquired Immunodeficiency Syndrome and CMV Viremia and/or Viruria
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Sevirumab
Sponsor:Sandoz Inc.
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00002268
Other IDs:071A,   Study No B102
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:December 1991
Acronym:
Primary Completion Date:
Outcome Measure:
25CompletedFoscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Foscarnet sodium
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:53
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000726
Other IDs:ACTG 015,   FDA 20D
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:February 1992
Acronym:
Primary Completion Date:
Outcome Measure:
26CompletedA Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:38
Funded By:NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000673
Other IDs:ACTG 085
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
27CompletedA Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Aldesleukin
Sponsor:Chiron Corporation
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Industry
Study Type:Interventional
Study Design:Endpoint Classification: Safety Study;   Primary Purpose: Treatment
NCT ID:NCT00002321
Other IDs:086A,   CS-L293-10
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:June 23, 2005
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
28RecruitingVaccine Therapy in Preventing Cytomegalovirus in Healthy Participants
Condition:Nonneoplastic Condition
Interventions:Biological: PADRE-CMV fusion peptide vaccine;   Biological: tetanus-CMV fusion peptide vaccine;   Drug: agatolimod sodium
Sponsors:City of Hope Medical Center;   National Cancer Institute (NCI)
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:96
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00722839
Other IDs:City of Hope 03121,   R01CA077544,   P30CA033572,   CHNMC-03121,   CDR0000599724
First Received Date:July 25, 2008
Start Date:December 2006
Completion Date:
Last Updated Date:March 24, 2011
Last Verified Date:March 2011
Acronym:
Primary Completion Date:September 2011
Outcome Measures:Successful completion of a series of 4 injections (at weeks 0, 3, 6, and 9) without dose-limiting toxicity;   Maximum tolerated dose of each vaccine with or without adjuvant CpG 7909;   Number of CMV-positive and CMV-specific CD8+ T cells/L
29CompletedA Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Interventions:Drug: Foscarnet sodium;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Astra USA;   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00000970
Other IDs:ACTG 151
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 31, 2008
Last Verified Date:October 1994
Acronym:
Primary Completion Date:
Outcome Measure:
30CompletedStem Cell Transplant, Chemotherapy, and Biological Therapy in Treating Patients With High-Risk or Refractory Multiple Myeloma
Condition:Multiple Myeloma and Plasma Cell Neoplasm
Interventions:Biological: CMV pp65 peptide;   Biological: hTERT I540/R572Y/D988Y multipeptide vaccine;   Biological: pneumococcal polyvalent vaccine;   Biological: survivin Sur1M2 peptide vaccine
Sponsors:University of Maryland Greenebaum Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:56
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00499577
Other IDs:CDR0000552988,   MSGCC-0610-GCC,   UPCC-0610-GCC
First Received Date:July 10, 2007
Start Date:December 2006
Completion Date:
Last Updated Date:February 26, 2011
Last Verified Date:August 2009
Acronym:
Primary Completion Date:February 2009
Outcome Measures:Toxicity at 21 and 28 days post-transplant;   T-cell responses against the hTERT vaccine as measured by tetramer assays at 100 days post-transplant;   Paraprotein levels in the blood or urine and serum free light chain analyses at 60 days and at 6 months post-transplant;   Cytotoxic T-cell responses against autologous myeloma cell at day 100 post-transplant via chromium-51 release or flow-based assays;   Maximum clinical response;   1 and 2-year event-free survival;   Overall survival rates;   CD4 and CD8 T-cell responses against cytomegalovirus (CMV) at days 60 and 100 post-transplantation by CFSE dye dilution assays;   Composite binding antibody responses at days 60 and day 100 post-transplant by ELISA
31RecruitingDonor Lymphocytes in Preventing and Treating Cytomegalovirus Infection or Adenovirus Infection in Patients Who Have Undergone Umbilical Cord Blood Transplant
Condition:Cancer
Interventions:Biological: allogeneic CMV/AdV-specific cytotoxic T lymphocytes;   Other: laboratory biomarker analysis
Sponsors:Baylor College of Medicine;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Supportive Care
NCT ID:NCT01017705
Other IDs:CDR0000659669,   BCM-H-23668
First Received Date:November 20, 2009
Start Date:November 2009
Completion Date:
Last Updated Date:April 9, 2010
Last Verified Date:December 2009
Acronym:
Primary Completion Date:March 2011
Outcome Measures:Safety of cytotoxic T-cell lymphocytes (CTL) as assessed by CTEP Active version of the NCI CTCAE at 30-45 days after CTL infusion;   Viral load of cytomegalovirus and adenovirus as assessed by PCR before CTL infusion and then weekly for up to 60 days after CTL infusion;   Reconstitution of antiviral immunity as assessed by ELISPOT assays or tetramer assays;   Systemic infections occurring within 6 months of CTL infusion;   Secondary graft failure as assessed for 30 days after CTL infusion
32Unknown Vaccine Therapy in Treating Patients Who Have Undergone a Donor Stem Cell Transplant and Have Cytomegalovirus Infection That Has Not Responded to Therapy
Condition:Cancer
Interventions:Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: immunologic technique;   Other: laboratory biomarker analysis
Sponsor:Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00509691
Other IDs:CDR0000557037,   PSCI-25114
First Received Date:July 30, 2007
Start Date:June 2007
Completion Date:
Last Updated Date:September 16, 2010
Last Verified Date:October 2007
Acronym:
Primary Completion Date:
Outcome Measures:Toxicity;   Treatment failure;   Safety;   Time to development of cytomegalovirus (CMV) specific immune reconstitution;   CMV DNA levels;   Time during post-infusion follow up at which the dominant CMV pp65 epitope for the donor is recognized by the cytotoxic t-cell lymphocyte recipient
33CompletedGene Therapy in Preventing Cancer in Patients With Premalignant Carcinoma of the Oral Cavity or Pharynx
Condition:Head and Neck Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:51
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00064103
Other IDs:CDR0000306522,   MDA-ID-00193,   NCI-6053
First Received Date:July 8, 2003
Start Date:June 2006
Completion Date:
Last Updated Date:March 2, 2011
Last Verified Date:January 2007
Acronym:
Primary Completion Date:
Outcome Measures:Safety at weeks 2-4 and then for 6 months;   Maximum tolerated dose of Ad5CMV-p53 gene administered as an oral rinse at weeks 2-4 and then for 6 months;   Transduction and efficiency of treatment as measured by Simon's optimal 2-stage design at weeks 2-4 and then for 6 months;   Effect of p53 gene transfer on molecular biomarkers of p53 activity reduction as measured by immunohistochemical staining at baseline and during courses 1 and 6
34RecruitingGene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy
Condition:Prostate Cancer
Interventions:Biological: Ad5-CMV-NIS;   Drug: liothyronine sodium;   Genetic: reverse transcriptase-polymerase chain reaction;   Other: laboratory biomarker analysis;   Radiation: iodine I 131
Sponsors:Mayo Clinic;   National Cancer Institute (NCI)
Gender:Male
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:24
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00788307
Other IDs:CDR0000618542,   P30CA015083,   MC0252,   06-009392,   NCI-2009-01195
First Received Date:November 7, 2008
Start Date:July 2009
Completion Date:
Last Updated Date:January 20, 2011
Last Verified Date:January 2011
Acronym:
Primary Completion Date:November 2011
Outcome Measures:Number of toxicity incidents by NCI CTCAE v3.0 criteria;   Time to PSA progression;   Survival;   Incidence and duration of PSA response;   Duration of PSA control
35CompletedVaccine Therapy in Treating Patients With Advanced or Metastatic Cancer
Conditions:Breast Cancer;   Colorectal Cancer;   Gallbladder Cancer;   Gastric Cancer;   Head and Neck Cancer;   Liver Cancer;   Ovarian Cancer;   Pancreatic Cancer;   Testicular Germ Cell Tumor
Interventions:Biological: CMV pp65 peptide;   Biological: autologous dendritic cells/CMV pp65 peptide mixture;   Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine;   Biological: tetanus toxoid;   Biological: therapeutic autologous dendritic cells
Sponsors:Duke University;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00027534
Other IDs:CDR0000069041,   DUMC-2840-02-6R1,   NCI-1864
First Received Date:December 7, 2001
Start Date:January 2002
Completion Date:
Last Updated Date:June 12, 2010
Last Verified Date:September 2005
Acronym:
Primary Completion Date:
Outcome Measure:
36RecruitingMulti-Virus-Specific Cytotoxic T Lymphocytes (CTLs)
Condition:Acute Lymphoblastic Leukemia
Intervention:Biological: Genetically modified T cells
Sponsors:Baylor College of Medicine;   Texas Children's Hospital;   The Methodist Hospital System;   Center for Cell and Gene Therapy, Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00840853
Other IDs:23637-MULTIPRAT
First Received Date:February 9, 2009
Start Date:April 2009
Completion Date:April 2029
Last Updated Date:March 4, 2011
Last Verified Date:March 2011
Acronym:MULTIPRAT
Primary Completion Date:April 2014
Outcome Measures:Evaluate safety/persistence of escalating doses of allogeneic CMV, EBV and Adenovirus specific CTLs modified to express artificial T-cell receptors targeting CD19 molecule given for prophylaxis, persistence or relapse of high risk B-cell ALL post HSCT;   To evaluate the effects of gene modified CTL on measurable disease.;   To evaluate the impact of the gene modified CTL on virus-specific T-lymphocyte immune reconstitution.;   To evaluate the impact of the gene modified CTL on normal CD19+ B-cell immune reconstitution post-HSCT.
37CompletedVaccine Therapy in Treating Patients With Refractory Stage IV Cancer
Condition:Unspecified Adult Solid Tumor, Protocol Specific
Interventions:Biological: CMV pp65 peptide;   Biological: carcinoembryonic antigen peptide 1-6D;   Biological: therapeutic autologous dendritic cells
Sponsors:Duke University;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:12
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00057915
Other IDs:CDR0000285629,   DUMC-4180-03-10R1,   NCI-5910
First Received Date:April 7, 2003
Start Date:September 2003
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:September 2006
Acronym:
Primary Completion Date:
Outcome Measure:
38CompletedCytomegalovirus Vaccine in Healthy Participants
Condition:Precancerous/Nonmalignant Condition
Intervention:Biological: CMVpp65-A*0201 peptide vaccine
Sponsors:City of Hope Medical Center;   National Cancer Institute (NCI)
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:46
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Masking: Double-Blind;   Primary Purpose: Treatment
NCT ID:NCT00712634
Other IDs:CDR0000599675,   P01CA030206,   CHNMC-97092
First Received Date:July 9, 2008
Start Date:November 1997
Completion Date:April 2009
Last Updated Date:December 18, 2009
Last Verified Date:December 2009
Acronym:
Primary Completion Date:April 2009
Outcome Measures:Safety and toxicity;   Immunologic response;   Duration of immunologic response
39Not yet recruitingSERCA Gene Therapy Trial
Conditions:Advanced Heart Failure;   Patients That Have Received a Left Ventricular Assist Device
Interventions:Genetic: AAV6.SERCA2a;   Procedure: Placebo
Sponsors:Imperial College London;   Leducq Foundation
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:16
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
NCT ID:NCT00534703
Other IDs:SERCA1,   EudraCT Number: 2007-002809-48
First Received Date:September 24, 2007
Start Date:January 2010
Completion Date:December 2012
Last Updated Date:August 3, 2009
Last Verified Date:August 2009
Acronym:
Primary Completion Date:December 2012
Outcome Measures:Level and extent of gene expression measured by PCR of SERCA;   Levels of SERCA protein;   Viral DNA and RNA;   Other relevant proteins e.g. phospholamban, the sarcoplasmic reticulum calcium release channel, the Na+/Ca2+-exchanger.;   Function of isolated myocytes (depending on availability of cardiac tissue);   Left ventricular function assessed by echocardiography;   Incidence of major adverse cardiovascular events (MACE) at 30 days
40CompletedA Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:48
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000668
Other IDs:ACTG 127,   ICM 1505,   FDA 37A,   RS-21592
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 25, 2008
Last Verified Date:March 1991
Acronym:
Primary Completion Date:
Outcome Measure:

RankStatusStudy
41CompletedGene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Condition:Lung Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Radiation: radiation therapy
Sponsors:Eastern Cooperative Oncology Group;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004225
Other IDs:CDR0000067466,   ECOG-8597
First Received Date:January 28, 2000
Start Date:January 2000
Completion Date:
Last Updated Date:July 3, 2010
Last Verified Date:April 2004
Acronym:
Primary Completion Date:
Outcome Measure:
42CompletedGene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
Condition:Breast Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Drug: chemotherapy
Sponsors:Fox Chase Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004038
Other IDs:CDR0000066480,   FCCC-97009,   NCI-T97-0042
First Received Date:December 10, 1999
Start Date:January 1999
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:June 2001
Acronym:
Primary Completion Date:
Outcome Measure:
43CompletedGene Therapy in Treating Patients With Recurrent Malignant Gliomas
Condition:Brain and Central Nervous System Tumors
Interventions:Biological: Ad5CMV-p53 gene;   Procedure: conventional surgery
Sponsors:North American Brain Tumor Consortium;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00004041
Other IDs:CDR0000066871,   NABTC-9703
First Received Date:December 10, 1999
Start Date:March 1999
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:December 2002
Acronym:
Primary Completion Date:
Outcome Measure:
44Unknown Gene Therapy in Treating Patients With Cancer of The Liver
Condition:Liver Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:University of Pittsburgh;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:30
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003147
Other IDs:CDR0000065932,   PCI-96-035,   NCI-T96-0059
First Received Date:April 6, 2000
Start Date:February 1998
Completion Date:
Last Updated Date:July 29, 2009
Last Verified Date:May 2000
Acronym:
Primary Completion Date:
Outcome Measure:
45CompletedGene Therapy in Treating Patients With Non-Small Cell Lung Cancer That Cannot Be Surgically Removed
Condition:Lung Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:Eastern Cooperative Oncology Group;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003649
Other IDs:CDR0000066741,   E-6597
First Received Date:November 1, 1999
Start Date:November 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:February 2002
Acronym:
Primary Completion Date:
Outcome Measure:
46Unknown Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
Conditions:Ovarian Cancer;   Peritoneal Cavity Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:Simmons Cancer Center;   National Cancer Institute (NCI)
Gender:Female
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003450
Other IDs:CDR0000066481,   UTSMC-089733300,   NCI-T97-0096
First Received Date:November 1, 1999
Start Date:September 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:June 2002
Acronym:
Primary Completion Date:
Outcome Measure:
47CompletedGene Therapy in Treating Patients With Advanced Bladder Cancer
Condition:Bladder Cancer
Intervention:Biological: Ad5CMV-p53 gene
Sponsors:M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003167
Other IDs:CDR0000065968,   MDA-DM-96172,   NCI-T96-0073
First Received Date:November 1, 1999
Start Date:May 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:December 2002
Acronym:
Primary Completion Date:
Outcome Measure:
48CompletedGene Therapy in Treating Patients With Ovarian Cancer
Condition:Ovarian Cancer
Interventions:Biological: Ad5CMV-p53 gene;   Procedure: laparoscopic surgery
Sponsors:M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Gender:Female
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00003588
Other IDs:CDR0000066657,   MDA-ID-97228,   NCI-T97-0111
First Received Date:November 1, 1999
Start Date:September 1998
Completion Date:
Last Updated Date:February 6, 2009
Last Verified Date:June 2002
Acronym:
Primary Completion Date:
Outcome Measure:
49CompletedVirus-Specific Cytotoxic T-Lymphocytes (CTLs) for Adenovirus Infection Following an Allogeneic Stem Cell Transplant
Condition:Adenoviridae Infections
Interventions:Genetic: Cytomegalovirus (CMV)-specific Cytotoxic T-Lymphocytes (CTL);   Genetic: Epstein-Barr Virus (EBV)-specific Cytotoxic T-Lymphocytes (CTL)
Sponsors:National Heart, Lung, and Blood Institute (NHLBI);   Baylor College of Medicine;   Texas Children's Hospital
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:NIH / Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00111033
Other IDs:436,   U54 HL081007-01,   LYPTAIST,   14097
First Received Date:May 16, 2005
Start Date:September 2003
Completion Date:June 2008
Last Updated Date:September 29, 2008
Last Verified Date:September 2008
Acronym:
Primary Completion Date:June 2008
Outcome Measure:Maximum tolerated dose of AdV-CTL (i.e., dose with the probability closest to the target toxicity rate at the following termination points: preinfusion, 24 hours post-infusion [optional], Day 3 or 4 [optional], and 1, 2, 4, 6, and 8 weeks post-infusion)
50Active, not recruitingEmergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
Condition:Cancer
Interventions:Biological: cytomegalovirus IE-1-specific cytotoxic T lymphocytes;   Biological: cytomegalovirus pp65-specific cytotoxic T lymphocytes;   Biological: therapeutic allogeneic lymphocytes;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: immunological diagnostic method;   Other: laboratory biomarker analysis
Sponsors:Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:20
Funded By:Other / NIH
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Supportive Care
NCT ID:NCT00769613
Other IDs:CDR0000615167,   PSCI-PSHCI-08-051
First Received Date:October 8, 2008
Start Date:August 2008
Completion Date:
Last Updated Date:September 18, 2010
Last Verified Date:August 2010
Acronym:
Primary Completion Date:August 2014
Outcome Measures:Safety;   Toxicity;   Time to development of cytomegalovirus (CMV)-specific immune reconstitution;   CMV DNA levels;   Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL);   Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors
51CompletedA Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
Conditions:Colitis;   HIV Infections
Interventions:Drug: Glutamic acid hydrochloride;   Drug: Ganciclovir
Sponsors:National Institute of Allergy and Infectious Diseases (NIAID);   Hoffmann-La Roche
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:24
Funded By:NIH / Industry
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Primary Purpose: Treatment
NCT ID:NCT00000768
Other IDs:ACTG 183
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 25, 2008
Last Verified Date:August 1998
Acronym:
Primary Completion Date:
Outcome Measure:
52CompletedA Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
Conditions:Cytomegalovirus Retinitis;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:25
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00001062
Other IDs:ACTG 278
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:August 1, 2008
Last Verified Date:December 1996
Acronym:
Primary Completion Date:
Outcome Measure:
53CompletedCandidate HIV Vaccine
Condition:HIV Infections
Intervention:Drug: VRC-HIVDNA016-00-VP
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:15
Funded By:NIH
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00089531
Other IDs:040254,   04-I-0254
First Received Date:August 5, 2004
Start Date:August 2004
Completion Date:January 2008
Last Updated Date:January 16, 2008
Last Verified Date:January 2008
Acronym:
Primary Completion Date:
Outcome Measure:
54CompletedT Lymphocytes and Anti-CD45 Monoclonal Antibody in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer
Condition:Head and Neck Cancer
Interventions:Biological: anti-CD45 monoclonal antibody;   Biological: autologous Epstein-Barr virus-specific cytotoxic T lymphocytes
Sponsor:Baylor College of Medicine
Gender:Both
Age Groups:Child / Adult / Senior
Phase:Phase I
Number Enrolled:18
Funded By:Other
Study Type:Interventional
Study Design:Primary Purpose: Treatment
NCT ID:NCT00608257
Other IDs:CDR0000582383,   BCM-H-14214,   BCM-CLANC
First Received Date:February 1, 2008
Start Date:September 2003
Completion Date:
Last Updated Date:April 18, 2009
Last Verified Date:November 2008
Acronym:
Primary Completion Date:November 2008
Outcome Measures:Maximum tolerated dose of autologous Epstein-Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in combination with anti-CD45 monoclonal antibody;   Safety;   Changes in laboratory data at baseline, 2, 4, 6, and 8 weeks and at 3 months;   Extent and duration of immune depletion at pre-antibody infusion, pre-CTL infusion, 4 hours after infusion on days 3 and 4, and at 1, 2, 4, 6, and 8 weeks post-CTL infusion;   Immunologic function as measured by interferon-gamma, percentage of tetramer-positive cells in peripheral blood, and EBV-DNA in plasma;   Frequency of T-cells specific for CMV antigens (or for adenovirus in CMV-seronegative individuals) and EBV antigens at each time point of follow-up;   Correlation between endogenously reconstituted versus adoptively transferred T-cells;   Overall response rate
55Active, not recruitingVaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Condition:Brain and Central Nervous System Tumors
Interventions:Biological: tetanus toxoid;   Biological: therapeutic autologous dendritic cells;   Biological: therapeutic autologous lymphocytes
Sponsors:Duke University;   National Cancer Institute (NCI)
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:16
Funded By:Other / NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00639639
Other IDs:CDR0000589624,   P50CA108786,   P30CA014236,   DUMC-PRO00003877,   DUMC-8108-07-1R1,   NCI-09-C-0038
First Received Date:March 19, 2008
Start Date:January 2006
Completion Date:
Last Updated Date:March 29, 2011
Last Verified Date:March 2011
Acronym:ATTAC
Primary Completion Date:June 2012
Outcome Measures:Feasibility and safety of vaccination with cytomegalovirus pp65-LAMP mRNA-loaded dendritic cells (DCs) with or without autologous lymphocyte transfer;   Humoral and cellular immune responses;   Time to progression;   Differential ability of indium In-111-labeled DCs to track to the inguinal lymph nodes under different skin preparative conditions;   Differential ability of indium In-111-labeled DCs to track to lymph nodes on the tumor bearing and non-tumor bearing side of the cervical lymph nodes;   Immunologic cell infiltrate in recurrent tumors;   Evidence of antigen-escape outgrowth in recurrent or progressive tumors
56Unknown Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies
Condition:Hematological Malignancies
Intervention:Drug: Thymosin alpha 1
Sponsor:University Of Perugia
Gender:Both
Group:Adult
Phases:Phase I / Phase II
Number Enrolled:9
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00580450
Other IDs:(ST 1472),   ST 1472 06/01/27
First Received Date:December 21, 2007
Start Date:December 2007
Completion Date:December 2010
Last Updated Date:December 21, 2007
Last Verified Date:November 2007
Acronym:
Primary Completion Date:December 2007
Outcome Measure:Efficacy in terms of improvement of immunological reconstitution, infectious mortality; safety as prevention of GvHD.
57RecruitingAlemtuzumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia
Conditions:Infection;   Leukemia
Interventions:Biological: alemtuzumab;   Genetic: polymerase chain reaction;   Other: flow cytometry;   Other: laboratory biomarker analysis;   Other: pharmacological study
Sponsor:German CLL Study Group
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:36
Funded By:Other
Study Type:Interventional
Study Design:Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00634881
Other IDs:CDR0000587746,   GCLLSG-CLL2I,   BAYER-GCLLSG-CLL2I,   EU-20816
First Received Date:March 12, 2008
Start Date:November 2003
Completion Date:
Last Updated Date:May 9, 2009
Last Verified Date:March 2008
Acronym:
Primary Completion Date:December 2011
Outcome Measures:Dose-limiting toxicity;   Maximum tolerated dose;   Rate of complete minimal residual disease response;   Rate of immunophenotypic remission using 4-color flow cytometry;   Rate of infections (especially CMV infections and reactivations);   Rate of severe hematologic and non-hematologic side effects;   Pharmacokinetics of alemtuzumab (after IV and subcutaneous administration);   Progression-free survival;   Overall survival;   Complete remission rate
58RecruitingAlemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas
Condition:Peripheral T-cell Lymphomas
Intervention:Drug: Alemtuzumab (Campath-1H)
Sponsors:Ontario Clinical Oncology Group (OCOG);   Sunnybrook Health Sciences Centre;   Genzyme
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:64
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00453427
Other IDs:CTA-Control-103662
First Received Date:March 27, 2007
Start Date:September 2006
Completion Date:June 2016
Last Updated Date:January 7, 2011
Last Verified Date:January 2011
Acronym:ACCAPELA
Primary Completion Date:June 2011
Outcome Measures:toxicity;   efficacy;   tumour response;   pharmacokinetic analysis;   immunological monitoring
59CompletedStudy of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma
Conditions:T-Cell Lymphoma;   Lymphoma, Non-Hodgkin's
Intervention:Drug: CHOP and alemtuzumab
Sponsors:Weill Medical College of Cornell University;   Bayer
Gender:Both
Age Groups:Adult / Senior
Phase:Phase I
Number Enrolled:
Funded By:Other / Industry
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00161590
Other IDs:0204-157
First Received Date:September 7, 2005
Start Date:July 2004
Completion Date:
Last Updated Date:October 21, 2008
Last Verified Date:October 2008
Acronym:
Primary Completion Date:
Outcome Measure:
60Unknown A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease
Conditions:Cytomegalovirus Infections;   HIV Infections
Intervention:Drug: Ganciclovir
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Age Groups:Child / Adult
Phase:Phase I
Number Enrolled:32
Funded By:NIH
Study Type:Interventional
Study Design:Endpoint Classification: Pharmacokinetics Study;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00000805
Other IDs:ACTG 226
First Received Date:November 2, 1999
Start Date:
Completion Date:
Last Updated Date:July 11, 2008
Last Verified Date:August 2004
Acronym:
Primary Completion Date:
Outcome Measure:
RankStatusStudy
61Unknown Infections and Autoimmunity: Autobodies Screening in Multiple Sclerosis
Condition:Multiple Sclerosis
Intervention:Procedure: Serum antibodies to infectious agents using the BioPlex 2200 and complementary EIA kits
Sponsor:Sheba Medical Center
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:100
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
NCT ID:NCT00230204
Other IDs:SHEBA-05-3868-AA-CTIL
First Received Date:September 29, 2005
Start Date:September 2005
Completion Date:April 2006
Last Updated Date:February 15, 2006
Last Verified Date:January 2006
Acronym:
Primary Completion Date:
Outcome Measures:Determine antibodies to infectious agents immunoglobulin G (IgG), IgM in patients with multiple sclerosis;   Assess correlation between antibody levels to various infectious agents with clinical disease variables
62CompletedVaccine for Prevention of Bird Flu
Condition:Influenza, Human
Interventions:Drug: Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005;   Drug: VRC-AViDNA036-00-VP
Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)
Gender:Both
Group:Adult
Phase:Phase I
Number Enrolled:60
Funded By:NIH
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
NCT ID:NCT00776711
Other IDs:090012,   09-I-0012
First Received Date:October 18, 2008
Start Date:October 2008
Completion Date:January 2011
Last Updated Date:January 15, 2011
Last Verified Date:January 2011
Acronym:
Primary Completion Date:January 2011
Outcome Measures:Safety (local and systemic reactogenicity, lab tests, AEs);   Immunogenicity (cellular and humoral immune function assays)
63CompletedCombined High Frequency Oscillation and Tracheal Gas Insufflation for Severe Acute Respiratory Distress Syndrome
Condition:Respiratory Distress Syndrome, Adult
Intervention:Other: High Frequency Oscillation and Tracheal Gas Insufflation
Sponsor:University of Athens
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:54
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00416260
Other IDs:10532-HFO-TGI
First Received Date:December 26, 2006
Start Date:July 2006
Completion Date:September 2007
Last Updated Date:February 23, 2009
Last Verified Date:February 2009
Acronym:
Primary Completion Date:September 2007
Outcome Measures:Physiological variables (i.e. ventilation pressures and oxygenation) during the first 7-10 days following randomization;   Survival to days 28 and 60 post-randomization and to Hospital Discharge;   Ventilator free days;   Number of Organ or system failure free days;   Occurence of Barotraumas/airway injury
64Active, not recruitingPhase I/II Clinical Trial Combining hTERT Tumor Vaccine & Autologous T Cells in Patients With Advanced Myeloma
Condition:Multiple Myeloma
Interventions:Biological: Telomerase (hTERT vaccine + pneumoccal conjugate vaccine (PCV));   Biological: PCV vaccine
Sponsors:University of Pennsylvania;   University of Maryland
Gender:Both
Age Groups:Adult / Senior
Phases:Phase I / Phase II
Number Enrolled:56
Funded By:Other
Study Type:Interventional
Study Design:Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
NCT ID:NCT00834665
Other IDs:UPCC 13406 / GCC610
First Received Date:January 3, 2008
Start Date:December 2006
Completion Date:December 2009
Last Updated Date:September 21, 2010
Last Verified Date:September 2010
Acronym:
Primary Completion Date:December 2009
Outcome Measures:Does combination therapy delay hematopoietic recovery or induce other autoimmune events.;   Does combination therapy generate cytotoxic T-cell responses to autologous myeloma cells in-vivo.




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