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

NCT00771017 | Withdrawn Phase 2

• 2 other identifiers: CDR0000616570ECOG-E3806
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage II prostate cancer; stage III prostate cancer; stage I prostate cancer

Outcome Measures

Primary Outcomes (1)

• Median PSA recurrence-free survival in patients in patients responding to the study treatments

Secondary Outcomes (3)

• Safety

• Effects of 6-month androgen ablation on thymic production of naïve T cells

• Median time to metastatic disease development

Study Arms (2)

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.

Drug: bicalutamide; Drug: goserelin; Drug: leuprolide acetate

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.

Biological: GVAX prostate cancer vaccine; Drug: bicalutamide; Drug: goserelin; Drug: leuprolide acetate

Interventions

GVAX prostate cancer vaccine BIOLOGICAL

Given intradermally

Arm II

bicalutamide DRUG

Given orally

Arm I; Arm II

goserelin DRUG

Given intramuscularly

Arm I; Arm II

leuprolide acetate DRUG

Given intramuscularly

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Goserelin; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Charles G. Drake, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

• Michael A. Carducci, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: July 1, 2008
• Last Updated: May 25, 2023

Record last verified: 2023-05