Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Brief summary
RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective treatment for localized prostate cancer. PURPOSE: This clinical trial is studying how well giving GM-CSF before surgery works in treating patients with localized prostate cancer.
Detailed description
OBJECTIVES: Primary * Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy. * Determine whether tissue-specific antiprostate cancer immunity is induced by the administration of neoadjuvant GM-CSF in patients with localized prostate cancer prior to radical prostatectomy. Secondary * Estimate the baseline antitumor immune response in patients treated with 2 different dose schedules of GM-CSF. * Determine the magnitude of the difference in immune response between 2 dose schedules of GM-CSF. * Determine the clinical effects, including prostate-specific antigen (PSA) decline, surgical outcome, surgical complications, and histologic appearance of surgical specimen, of this regimen in these patients. OUTLINE: This is a pilot study. Patients are stratified according to sargramostim (GM-CSF) dose. Patients receive 1 of 2 dose levels of GM-CSF subcutaneously on days 1-14 or 1-21. Treatment continues in the absence of unacceptable toxicity. Within 3 days after the last dose of GM-CSF, patients undergo radical prostatectomy. Blood is collected at baseline, day 28 of each course, and at the 4-week follow-up visit and is examined for activated T-cells. Tissue is collected during surgery and assessed for biomarkers and cytokines. After completion of study treatment, patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the prostate * No neuroendocrine or small cell features * No evidence of metastatic disease * Planning radical prostatectomy at least 2 months from now * Testosterone level normal PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8 g/dL * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN * PT and PTT normal * Fertile patients must use effective barrier contraception * No history of allergic reaction to compounds of similar chemical or biologic composition to sargramostim (GM-CSF) * No ongoing or active bacterial, viral, or fungal infection * DLCO \> 50% if patient has a history of clinically significant obstructive airway disease * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No other active malignancy, defined as cancer for which therapy has been completed and patient is now considered \< 30% risk of relapse, except nonmelanoma skin cancer * No psychiatric illness or social situation that would preclude study compliance * No other uncontrolled illness * No underlying medical condition that, in the opinion of the principal investigator, may make the administration of GM-CSF hazardous or obscure the interpretation of adverse events PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior major surgery * No prior radiotherapy, immunotherapy, chemotherapy, or other investigational therapy for this cancer * No prior hormonal therapy including any of the following: * Luteinizing-hormone releasing hormone (LHRH) agonists * LHRH antagonists * Antiandrogens, including any of the following: * Bilcalutamide * Flutamide * Nilutamide * 5-alpha-reductase inhibitors * PC-SPES or other PC-x product * Estrogen-containing nutriceuticals * No concurrent chemotherapy or radiotherapy * No concurrent systemic steroid therapy * Concurrent inhaled or topical steroids allowed * No other concurrent immunotherapy * No other concurrent investigational agent * No other concurrent anticancer agents or therapies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy. | up to 6 weeks following surgery |
Countries
United States