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

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Biological: sargramostim
Drug: thalidomide
Procedure: conventional surgery
Procedure: neoadjuvant therapy

Registration Number: NCT00400517

Lead Sponsor: The Cleveland Clinic

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 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.

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) 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GM-CSF Injections and Oral Thalidomide	sargramostim	taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.
GM-CSF Injections and Oral Thalidomide	conventional surgery	taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.
GM-CSF Injections and Oral Thalidomide	neoadjuvant therapy	taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.
GM-CSF Injections and Oral Thalidomide	thalidomide	taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.

Primary Outcome Measures

Name	Time	Method
Prostate-specific Antigen Response	8 weeks	Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.
Proportion of Patients P0 at Surgery	8 weeks	Pathologic Complete Response is defined as complete eradication of tumor.
Time to Clinical Progression	32 months	Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.
Proportion of Patients With Negative Surgical Margins	8 Weeks	Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.