GM-CSF in Treating Patients With Relapsed Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: sargramostim
Intervention description: Given subcutaneously on varying schedule
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer

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