Status:
WITHDRAWN
Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE2
Brief Summary
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. Vac...
Detailed Description
OBJECTIVES: Primary * 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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Biochemically relapsed prostate cancer
- Must have received primary therapy (i.e., radical prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy)
- If patient has a rising PSA after radical prostatectomy, salvage radiotherapy must have been offered
- Evidence of biochemical progression as determined by 3 PSA measurements, each higher than the previous value and meeting the following criteria:
- The second PSA (PSA2) must be obtained at least 8 weeks after the first (PSA1)
- The third PSA (PSA3) must be obtained at least 2 weeks after the PSA2 and within the past 4 weeks
- The PSA3 must be \> 2.0 ng/mL and ≤ 20 ng/mL
- Must not have received more than 1 course of prior androgen ablation, defined as treatment with a luteinizing hormone-releasing hormone agonist resulting in a castrate testosterone level AND a PSA nadir ≤ 0.1 followed by subsequent withdrawal of androgen ablation and recovery of testosterone to a non-castrate level
- No evidence of metastatic disease on radionuclide bone scan and CT scan performed within the past 8 weeks
- Retroperitoneal lymphadenectomy ≤ 2 cm is not considered metastatic for purposes of this study
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC \> 2,500/mm³
- ANC ≥ 1,500/mm³
- Hemoglobin \> 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- PT/INR ≤ 1.3
- Serum testosterone normal
- Fertile patients must use effective contraception
- No active autoimmune disease or history of autoimmune disease requiring treatment with systemic immunosuppression including, but not limited to, any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Systemic vasculitis
- Scleroderma
- Multiple sclerosis
- Hemolytic anemia
- Sjögren syndrome
- Sarcoidosis
- No known active infection
- No uncontrolled concurrent illness including, but not limited to, any of the following:
- Systemic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide acetate, bicalutamide, or sargramostim (GM-CSF)
- No known sensitivity to materials of bovine origin
- No hypersensitivity to GM-CSF or to any of the other components of CG1940/CG8711, which includes fetal bovine serum, dimethyl sulfoxide (DMSO), and hydroxyethyl starch and may include small amounts of porcine trypsin and DNase
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior and no concurrent systemic corticosteroids
- Use of inhaled corticosteroids for asthma or chronic obstructive pulmonary disease (COPD) is permitted
- More than 4 weeks since prior and no concurrent chemotherapy or other cancer therapy
- More than 4 weeks since prior and no concurrent use of herbal products (e.g., saw palmetto or PC-SPES)
- At least 4 weeks since prior and no other concurrent investigational agents
- No other concurrent anticancer commercial agents or therapies
- Prior androgen ablation administered concomitantly with primary radiotherapy allowed
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00771017
Start Date
July 1 2008
Last Update
May 25 2023
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