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

Prostate Cancer Clinical Trial

Official title:

Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400517
• Other study ID #: CASE-CCF-4643
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 2
• Start date: March 2003
• Est. completion date: June 2008

Study information

• Verified date: July 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Drug:
• thalidomide
doses up to 400 mg/day

Procedure:
• conventional surgery
SOC care surgery
• neoadjuvant therapy
post radical prostatectomy

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients P0 at Surgery	Pathologic Complete Response is defined as complete eradication of tumor.	8 weeks
Primary	Proportion of Patients With Negative Surgical Margins	Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.	8 Weeks
Primary	Prostate-specific Antigen Response	Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.	8 weeks
Primary	Time to Clinical Progression	Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.	32 months