Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: November 16, 2006
Last updated: April 18, 2017
Last verified: April 2017

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 Intervention Phase
Prostate Cancer
Biological: sargramostim
Drug: thalidomide
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

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

Enrollment: 28
Study Start Date: March 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: The Cleveland Clinic Identifier: NCT00400517     History of Changes
Other Study ID Numbers: CASE-CCF-4643
P30CA043703 ( US NIH Grant/Contract Award Number )
Study First Received: November 16, 2006
Last Updated: April 18, 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 processed this record on April 28, 2017