Phase 2
N=17
GM-CSF in Treating Patients With Relapsed Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00908141 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Aug 2013
Primary outcome: Primary: Prostate Specific Antigen (PSA) Response — 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sargramostim (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prostate Specific Antigen (PSA) Response |
2; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00908141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.