Prostate Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00305669

Recruitment Status:

Completed

Sponsor:

University of California, San Francisco

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There is 1 Location for this study

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UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT00305669

Recruitment Status:

Completed

Sponsor:


University of California, San Francisco

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