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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00400517
First received: November 16, 2006
Last updated: May 13, 2011
Last verified: January 2007
  Purpose

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: Masking: Open Label
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 [ Designated as safety issue: No ]
  • Proportion of patients with negative surgical margins [ Designated as safety issue: No ]
  • Prostate-specific antigen response [ Designated as safety issue: No ]
  • Time to clinical progression [ Designated as safety issue: No ]

Estimated Enrollment: 29
Study Start Date: March 2003
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00400517

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Robert Dreicer, MD, FACP Case Comprehensive Cancer Center
Principal Investigator: Eric Klein, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00400517     History of Changes
Other Study ID Numbers: CASE-CCF-4643, P30CA043703, CASE-CCF-4643, CELGENE-CASE-CCF-4643, BRLX-CASE-CCF-4643
Study First Received: November 16, 2006
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014