Status:
COMPLETED
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blo...
Detailed Description
OBJECTIVES: * Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA)...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease:
- Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen \[PSA\])
- Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)
- Serum PSA ≥ 10 ng/dL (any grade or stage)
- Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram
- No clinical evidence of CNS metastases
- No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry
- Appropriate medical candidate for radical prostatectomy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Creatinine ≤ 2.0 mg/dL
- Granulocyte count ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm³
- AST \< 3 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
- No active unresolved infection
- No pre-existing peripheral neuropathy \> grade 1
- No known HIV positivity
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of the bladder
- No known contraindication to sargramostim (GM-CSF) or thalidomide
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the prostate or pelvis
- No prior chemotherapy or hormonal therapy for prostate cancer
- No parenteral antibiotics within the past 7 days
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00400517
Start Date
March 1 2003
End Date
June 1 2008
Last Update
August 28 2018
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195