GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
This study has been completed.
Sponsor:
The Cleveland Clinic
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
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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 |
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
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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013