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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00771017 |
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens made by the body. Vaccine therapy may help the body build an effective immune response to kill tumor cells. It is not yet known whether androgen ablation therapy is more effective with or without vaccine therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well it works when given together with or without vaccine therapy in treating patients with prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: GVAX prostate cancer vaccine Drug: bicalutamide Drug: goserelin Drug: leuprolide acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized, Phase II Trial of Brief Androgen-Ablation Combined With Cell-Based CG1940/CG8711 Immunotherapy For Prostate Cancer in Patients With Non-Metastatic, Biochemically Relapsed Prostate Cancer |
Estimated Enrollment: | 126 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment comprising leuprolide acetate or goserelin intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
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Drug: bicalutamide
Given orally
Drug: goserelin
Given intramuscularly
Drug: leuprolide acetate
Given intramuscularly
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Arm II: Experimental
Patients receive androgen ablation as in arm I. Patients receive GVAX prostate cancer vaccine (CG1940 and CG8711) intradermally (ID) on day 1. Beginning on day 1 of week 3, patients receive booster doses of CG1940 and CG8711 ID every 2 weeks for 24 weeks.
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Drug: GVAX prostate cancer vaccine
Given intradermally
Drug: bicalutamide
Given orally
Drug: goserelin
Given intramuscularly
Drug: leuprolide acetate
Given intramuscularly
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (> 7 vs ≤ 7), PSA doubling time (< 3 months vs 3-9 months vs > 9 months) and prior androgen ablation (yes vs no). Patients are randomized to 1 of 2 treatment arms at a 1 (arm I):2 (arm II) ratio.
Patients are evaluated on day 1 of week 25 to assess disease. If PSA > 0.5 ng/mL AND there is no evidence of metastatic disease on imaging studies, then patients can be treated at the discretion of the investigator. If PSA ≤ 0.5 ng/mL, and there is no evidence of metastatic disease, then patients are considered responders and continue having PSA evaluated every 4 weeks until PSA relapse.
After completion of study therapy, patients are followed periodically for 5 years and then annually thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Must have received primary therapy (i.e., radical prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy)
Evidence of biochemical progression as determined by 3 PSA measurements, each higher than the previous value and meeting the following criteria:
No evidence of metastatic disease on radionuclide bone scan and CT scan performed within the past 8 weeks
PATIENT CHARACTERISTICS:
No active autoimmune disease or history of autoimmune disease requiring treatment with systemic immunosuppression including, but not limited to, any of the following:
No uncontrolled concurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior and no concurrent systemic corticosteroids
Study Chair: | Charles G. Drake, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000616570, ECOG-E3806 |
Study First Received: | October 9, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00771017 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer stage II prostate cancer stage III prostate cancer stage I prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Leuprolide Goserelin Bicalutamide |
Urogenital Neoplasms Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Pharmacologic Actions |
Neoplasms Androgen Antagonists Neoplasms by Site Therapeutic Uses Fertility Agents, Female Fertility Agents |