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

NCT ID: NCT00400517

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2008-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GM-CSF Injections and Oral 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.

Group Type: EXPERIMENTAL

sargramostim

Intervention Type: BIOLOGICAL

administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day

thalidomide

Intervention Type: DRUG

doses up to 400 mg/day

conventional surgery

Intervention Type: PROCEDURE

SOC care surgery

neoadjuvant therapy

Intervention Type: PROCEDURE

post radical prostatectomy

Interventions

sargramostim

administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day

Intervention Type: BIOLOGICAL

thalidomide

doses up to 400 mg/day

Intervention Type: DRUG

conventional surgery

SOC care surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

post radical prostatectomy

Intervention Type: PROCEDURE

Other Intervention Names

GM-CSF; THALOMID

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Garcia, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Eric Klein, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CCF-4643

Identifier Type: OTHER

Identifier Source: secondary_id

CELGENE-CASE-CCF-4643

Identifier Type: OTHER

Identifier Source: secondary_id

BRLX-CASE-CCF-4643

Identifier Type: OTHER

Identifier Source: secondary_id

CASE-CCF-4643

Identifier Type: -

Identifier Source: org_study_id