GM-CSF in Treating Patients With Relapsed Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Biological: sargramostim

• Registration Number: NCT00908141
• Lead Sponsor: Case Comprehensive Cancer Center

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).

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Results First Submitted: 2013-05-20
• Results First Submitted QC: 2013-05-20
• Status Verified: 2013-08
• Results First Posted: 2013-08-09
• Last Update Submitted: 2013-08-15
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II: sargramostim (3xweek)	sargramostim	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.
Arm I: sargramostim (days1-14)	sargramostim	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.

Primary Outcome Measures

Name	Time	Method
Prostate Specific Antigen (PSA) Response	post treatment at 9 weeks	The number of patients with PSA modulation defined as PSA decline of at least 50%

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States