GM-CSF in Treating Patients With Relapsed Prostate Cancer

NCT00908141 | Completed Phase 2 Results DMC

• 3 other identifiers: CASE6805P30CA0437038201
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I: sargramostim (days1-14)

EXPERIMENTAL

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.

Biological: sargramostim

Arm II: sargramostim (3xweek)

EXPERIMENTAL

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.

Biological: sargramostim

Interventions

sargramostim BIOLOGICAL

Given subcutaneously on varying schedule

Arm I: sargramostim (days1-14); Arm II: sargramostim (3xweek)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Robert Dreicer MD
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

dreicer@ccf.org

216-445-4623

Study Officials

• Robert Dreicer, MD, FACP

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2009
• First Posted: May 25, 2009
• Study Start: June 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 23, 2013
• Results First Posted: August 9, 2013

Record last verified: 2013-08

Locations

US (1)