Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

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 lenalidomide together with GM-CSF may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with GM-CSF and to see how well it works in treating patients with prostate cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Dreicer MD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lenalidomide; Sargramostim; Thalidomide

Criteria

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