Status:
COMPLETED
GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE1
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 localize...
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 whethe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00305669
Start Date
July 1 2006
End Date
June 1 2014
Last Update
June 25 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115