GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Male

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 blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.

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

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sargramostim; Thalidomide

Criteria

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