Status:
COMPLETED
Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
Lead Sponsor:
Robert Dreicer MD
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. Giving l...
Detailed Description
OBJECTIVES: * Establish the safety of a predetermined target dose or, if the target dose is not tolerable, find the maximum tolerated dose of lenalidomide when administered in combination with sargra...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Androgen-independent disease
- Testosterone ≤ 50 ng/mL
- Is currently receiving luteinizing hormone-releasing hormone agonists as maintenance or has undergone prior orchiectomy for testosterone suppression
- Progressive disease, as defined by ≥ 1 of the following:
- Clinical or radiographic evidence of metastases that have progressed irrespective of PSA changes
- Asymptomatic (non-opioid requiring) bone-only metastatic disease with a rising PSA on separate measurements ≥ 1 week apart
- No symptomatic bone metastases
- Biochemical progression (PSA-only disease), defined as having an absolute PSA value of ≥ 2.0 ng/mL on 3 separate measurements ≥ 2 weeks apart with a PSA doubling time of ≤ 10 months
- No evidence of CNS (brain or leptomeningeal) metastases or pleural and/or pericardial effusions
- PATIENT CHARACTERISTICS:
- ECOG performance status of 0-1
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Serum creatinine ≤ 2.0 mg/dL
- AST \< 3 times normal
- Bilirubin \< 1.5 mg/dL
- PT and PTT normal
- Calcium normal
- Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy
- Agrees to abstain from donating blood, semen, or sperm during and for ≥ 28 days after completion of study therapy
- No pre-existing peripheral neuropathy \> grade 1
- No active unresolved infection
- No known contraindication to lenalidomide or sargramostim
- No other malignancies within the past 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or stage Ta transitional cell carcinoma of the bladder
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy for metastatic prostate cancer
- More than 1 year since prior adjuvant and/or neoadjuvant therapy
- More than 4 weeks since prior flutamide (6 weeks for other antiandrogens)
- No prior thalidomide or lenalidomide
- At least 4 weeks since prior surgery or external-beam radiotherapy and recovered
- At least 6 weeks since prior radiopharmaceutical therapy, including samarium-153 or strontium-89, and recovered
- No initiation of bisphosphonate therapy within 1 month before and during study therapy
- Patients on stable doses of bisphosphonates who show subsequent tumor progression may continue to receive bisphosphonates
- Concurrent daily aspirin for the prevention of thrombotic events required
- Patients intolerant to aspirin may receive low-dose warfarin as prophylaxis
- No other concurrent investigational agents
- No other concurrent anticancer therapy, including radiotherapy or thalidomide
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00939510
Start Date
July 1 2005
End Date
December 1 2012
Last Update
January 31 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195