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Sponsors and Collaborators: |
Providence Health Care Providence Cancer Center, Earle A. Chiles Research Institute Cell Genesys |
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Information provided by: | Providence Health Care |
ClinicalTrials.gov Identifier: | NCT00122005 |
Androgen (a male sex hormone) deprivation is the standard therapy for metastatic prostate cancer and results in regression or control of disease in 80-85% of patients. This hormone therapy results in a progression-free survival of 12-18 months and overall survival of 24-30 months. However, all patients ultimately develop hormone-refractory prostate cancer (HRPC). Management of HRPC patients is a significant challenge for both patient and physician. Neither past nor current chemotherapy regimens have shown curative potential in patients with HRPC. Thus new treatment strategies are a high priority.
A major focus of new treatment strategies is to enlist the aid of the immune system, particularly the development of prostate cancer vaccines. There has been a number of studies using dendritic cell based vaccines and the treatment has been well tolerated. Specific T-cell immune responses have been observed and occasional evidence for tumor regression. A reduction in serum prostate-specific antigen (PSA) has been observed as well. Lengthening the time-to-progression and delays in the onset of bone pain have been observed in subsets of patients with HRPC.
The initial preclinical observations suggesting that a granulocyte-macrophage colony-stimulating factor (GM-CSF) gene transduced allogeneic (GVAX) prostate cancer vaccine may be efficacious in poorly immunogenic cancers were reported.
The objective of this study is to evaluate the safety and immunologic effects of vaccinations with Allogeneic Prostate GVAX® (CG1940 & CG8711) in patients made lymphopenic by treatment with chemotherapy and infused with autologous peripheral blood mononuclear cells (PBMC). Clinical observations and laboratory measurements will be monitored to evaluate safety, toxicity and immune responses. Additionally, the effects of treatment on serum PSA levels and tumor response will be evaluated.
Condition | Intervention | Phase |
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Prostate Cancer |
Biological: GM-CSF gene transduced allogeneic vaccine GVAX |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Human GM-CSF Gene-Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (GVAX®) in Advanced Prostate Cancer Patients Made Lymphopenic and Infused With Autologous Peripheral Blood Mononuclear Cells |
Estimated Enrollment: | 18 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Justice, RN | 503 215-2691 | lisa.justice@providence.org |
Contact: Theresa Ratzow, RN | 503 215-2604 | theresa.ratzow@providence.org |
United States, Oregon | |
Providence Portland Medical Center | Recruiting |
Portland, Oregon, United States, 97213 | |
Contact: Lisa Justice, RN 503-215-2691 lisa.justice@providence.org | |
Contact: Theresa Ratzow, RN 503 215-2604 theresa.ratzow@providence.org | |
Principal Investigator: Walter Urba, MD, PhD | |
Sub-Investigator: Brendan Curti, MD |
Principal Investigator: | Bernard Fox, PhD | Providence Health Care |
Study ID Numbers: | PPMC-EACRI-IRB-02-119, DOD Grant #DAMD17-03-1-0097 |
Study First Received: | July 18, 2005 |
Last Updated: | September 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00122005 |
Health Authority: | United States: Food and Drug Administration |
Metastatic Prostate Advanced |
Cancer GVAX Vaccine |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |