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GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer

A Pilot Study of Two Dose Schedules of Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00305669
Enrollment
24
Registered
2006-03-22
Start date
2006-07-31
Completion date
2014-06-30
Last updated
2014-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

BIOLOGICALsargramostim
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis
PROCEDUREconventional surgery
PROCEDUREneoadjuvant therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026