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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400517
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : April 20, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: sargramostim Drug: thalidomide Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
Study Start Date : March 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Thalidomide

Arm Intervention/treatment
Experimental: 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.
Biological: sargramostim
administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
Other Name: GM-CSF

Drug: thalidomide
doses up to 400 mg/day
Other Name: THALOMID

Procedure: conventional surgery
SOC care surgery

Procedure: neoadjuvant therapy
post radical prostatectomy

Primary Outcome Measures :
  1. Proportion of patients P0 at surgery [ Time Frame: 8 weeks ]
  2. Proportion of patients with negative surgical margins [ Time Frame: 8 Weeks ]
  3. Prostate-specific antigen response [ Time Frame: 8 weeks ]
  4. Time to clinical progression [ Time Frame: 8 weeks ]

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400517

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Principal Investigator: Robert Dreicer, MD, FACP Case Comprehensive Cancer Center
Principal Investigator: Eric Klein, MD Case Comprehensive Cancer Center

Responsible Party: The Cleveland Clinic Identifier: NCT00400517     History of Changes
Other Study ID Numbers: CASE-CCF-4643
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by The Cleveland Clinic:
stage III prostate cancer
stage II prostate cancer
adenocarcinoma of the prostate
stage I prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents