GM-CSF in Treating Patients With Relapsed Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908141
• Other study ID #: CASE6805
• Secondary ID: P30CA043703CASE6
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2009
• Last updated: August 15, 2013
• Start date: June 2006
• Est. completion date: July 2010

Study information

• Verified date: August 2013
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Non-metastatic, recurrent systemic disease as manifested by a rising PSA, defined as = 2 consecutive rises in PSA to be documented over a reference value (measure 1)

• The first rising PSA (measure 2) should be at taken = 14 days after the reference value

• A third confirmatory PSA measure is required (second beyond the reference level) to be greater than the second, and it must be obtained = 14 days after the second measure

• If this is not the case, a fourth PSA is required to be taken and be greater than the second measure

• No local-only relapse

• Must have undergone prior definitive therapy for prostate cancer consisting of external beam radiotherapy, brachytherapy (with or without external beam radiotherapy), or radical prostatectomy (with or without adjuvant androgen ablation)

• Patients who have not undergone definitive therapy as above or who have undergone hormonal therapy alone are not eligible

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• sargramostim
Given subcutaneously on varying schedule

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Specific Antigen (PSA) Response	The number of patients with PSA modulation defined as PSA decline of at least 50%	post treatment at 9 weeks	No