Back to resultsGM-CSF in Treating Patients With Relapsed Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sargramostim
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer
Eligibility Criteria
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
Sites / Locations
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I: sargramostim (days1-14)
Arm II: sargramostim (3xweek)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Prostate Specific Antigen (PSA) Response
The number of patients with PSA modulation defined as PSA decline of at least 50%
Secondary Outcome Measures
Full Information
NCT ID
NCT00908141
First Posted
May 22, 2009
Last Updated
August 15, 2013
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00908141
Brief Title
GM-CSF in Treating Patients With Relapsed Prostate Cancer
Official Title
Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I: sargramostim (days1-14)
Arm Type
Experimental
Arm Description
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 Title
Arm II: sargramostim (3xweek)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Description
Given subcutaneously on varying schedule
Primary Outcome Measure Information:
Title
Prostate Specific Antigen (PSA) Response
Description
The number of patients with PSA modulation defined as PSA decline of at least 50%
Time Frame
post treatment at 9 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Dreicer, MD, FACP
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GM-CSF in Treating Patients With Relapsed Prostate Cancer
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