GM-CSF in Treating Patients With Relapsed Prostate Cancer

NCT ID: NCT00908141

Last Updated: 2013-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-07-31

Brief Summary

RATIONALE: Colony stimulating factors, such as GM CSF, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known which GM-CSF regimen is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well GM-CSF works in treating patients with relapsed prostate cancer.

Detailed Description

OBJECTIVES:

Primary

• To determine the ability of sargramostim (GM-CSF) to increase the number and activation of dendritic cells (DC) in patients with biochemically relapsed prostate cancer.

Secondary

• To determine the effect of administration schedule and hormonal state on sargramostim-induced DC number and activation in these patients.
• To correlate the effects of sargramostim on DC number and activation with effects on prostate-specific antigen (PSA) modulation.
• To determine whether sargramostim administration generates antiprostate cancer immune responses in these patients.

OUTLINE: Patients are stratified according to hormonal status (androgen-dependent vs androgen-independent). Patients are then randomized to 1 of 2 treatment arms.

• Arm I: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive GM-CSF SC three times weekly for 4 weeks. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for dendritic cell (DC) number by flow cytometry, DC activation by quantitative real-time polymerase chain reaction (QRT-PCR), and immunity by serological analysis of recombinant cDNA expression libraries (SEREX).

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I: sargramostim (days1-14)

Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

sargramostim

Intervention Type: BIOLOGICAL

Given subcutaneously on varying schedule

Arm II: sargramostim (3xweek)

Patients receive GM-CSF SC three times weekly for 4 weeks. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

sargramostim

Intervention Type: BIOLOGICAL

Given subcutaneously on varying schedule

Interventions

sargramostim

Given subcutaneously on varying schedule

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• No evidence of metastases on bone or CT scan

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Leukocytes ≥ 3,000/μl
• Absolute neutrophil count ≥ 1,500/μl
• Platelets ≥ 100,000/μl
• Total bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• No active thrombophlebitis or disseminated intravascular coagulopathy
• No history of pulmonary embolus
• No history of immunodeficiency or autoimmune diseases
• No uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior systemic chemotherapy for any reason
• No concurrent anticoagulation therapy (i.e., therapeutic coumadin)

• Prophylactic anticoagulation (e.g., aspirin) allowed
• No concurrent systemic corticosteroids or other immunosuppressives

• Inhaled or topical steroids allowed

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Dreicer, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE6805

Identifier Type: OTHER

Identifier Source: secondary_id

8201

Identifier Type: OTHER

Identifier Source: secondary_id

CASE6805

Identifier Type: -

Identifier Source: org_study_id