Prostate Cancer Clinical Trial

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

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.

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Full 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) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy.
Determine the safety and feasibility of GM-CSF and thalidomide.

OUTLINE: This is an open-label study.

Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity.

Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT00400517

Recruitment Status:

Completed

Sponsor:

The Cleveland Clinic

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There is 1 Location for this study

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Cleveland Clinic
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT00400517

Recruitment Status:

Completed

Sponsor:


The Cleveland Clinic

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