Status:
COMPLETED
GM-CSF in Treating Patients With Relapsed Prostate Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Colony stimulating factors, such as GM CSF, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known which GM-CSF regimen is more effective in t...
Detailed Description
OBJECTIVES: Primary * To determine the ability of sargramostim (GM-CSF) to increase the number and activation of dendritic cells (DC) in patients with biochemically relapsed prostate cancer. Second...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Non-metastatic, recurrent systemic disease as manifested by a rising PSA, defined as ≥ 2 consecutive rises in PSA to be documented over a reference value (measure 1)
- The first rising PSA (measure 2) should be at taken ≥ 14 days after the reference value
- A third confirmatory PSA measure is required (second beyond the reference level) to be greater than the second, and it must be obtained ≥ 14 days after the second measure
- If this is not the case, a fourth PSA is required to be taken and be greater than the second measure
- No local-only relapse
- Must have undergone prior definitive therapy for prostate cancer consisting of external beam radiotherapy, brachytherapy (with or without external beam radiotherapy), or radical prostatectomy (with or without adjuvant androgen ablation)
- Patients who have not undergone definitive therapy as above or who have undergone hormonal therapy alone are not eligible
- No evidence of metastases on bone or CT scan
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Leukocytes ≥ 3,000/μl
- Absolute neutrophil count ≥ 1,500/μl
- Platelets ≥ 100,000/μl
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- No active thrombophlebitis or disseminated intravascular coagulopathy
- No history of pulmonary embolus
- No history of immunodeficiency or autoimmune diseases
- No uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy for any reason
- No concurrent anticoagulation therapy (i.e., therapeutic coumadin)
- Prophylactic anticoagulation (e.g., aspirin) allowed
- No concurrent systemic corticosteroids or other immunosuppressives
- Inhaled or topical steroids allowed
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00908141
Start Date
June 1 2006
End Date
July 1 2010
Last Update
August 23 2013
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195