Overview

Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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. 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Androgens
Bicalutamide
Goserelin
Leuprolide
Vaccines
Criteria
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