Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00771017|
Recruitment Status : Withdrawn
First Posted : October 10, 2008
Last Update Posted : August 20, 2013
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: GVAX prostate cancer vaccine Drug: bicalutamide Drug: goserelin Drug: leuprolide acetate||Phase 2|
- To determine the median PSA recurrence-free survival of patients with nonmetastatic, biochemically relapsed prostate cancer who respond with a PSA ≤ 0.5 ng/mL when administered a brief (6-month) course of androgen ablation either alone or in combination with GVAX prostate cancer vaccine (CG1940/CG8711) immunotherapy.
- To determine the safety of combined treatment with androgen ablation and CG1940/CG8711 immunotherapy in these patients.
- To determine median time to metastatic disease development in these patients.
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.
- Arm I (androgen-ablation therapy): 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.
- Arm II (androgen-ablation therapy and vaccine): Patients receive androgen ablation as in arm I. Patients also 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (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|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||April 2010|
Active Comparator: Arm I
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.
Drug: leuprolide acetate
Experimental: Arm II
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.
Biological: GVAX prostate cancer vaccine
Drug: leuprolide acetate
- Median PSA recurrence-free survival in patients in patients responding to the study treatments
- Effects of 6-month androgen ablation on thymic production of naïve T cells
- Median time to metastatic disease development
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771017
|Study Chair:||Charles G. Drake, MD, PhD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|OverallOfficial:||Michael A. Carducci, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|