Clinical trial · Interventional
GM-CSF in Treating Patients With Relapsed Prostate Cancer
Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer
NCT00908141CI-TRIAL-00011832completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: sargramostim (days1-14)
- 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.
- interventionNames
- Biological: sargramostim
- type
- EXPERIMENTAL
- label
- Arm II: sargramostim (3xweek)
- 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.
- interventionNames
- Biological: sargramostim
Primary outcomes (1)
- measure
- Prostate Specific Antigen (PSA) Response
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 allowedReferences
Publications (0)
Data not yet available
No reference posted for this study.