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Phase 2 N=17 Randomized Treatment

GM-CSF in Treating Patients With Relapsed Prostate Cancer

Prostate Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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