GM-CSF for Maintenance of Prostate Cancer for Patients Responding to Taxotere
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: GM CSF
Intervention description: 250 ug/m2 daily for 2 weeks followed by 2 weeks of rest
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is designed to investigate the efficacy and safety of GM-CSF used as a maintenance
      program in patients with androgen-independent prostate cancer (AIPC) who have achieved a
      maximal response on a taxotere or other chemotherapy schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men >18 years of age. No upper age limit

          2. Written informed consent approved by institutional review board should be explained to
             and signed by patient

          3. Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason
             score of any sum is allowed on this study.

          4. Metastatic disease as evidenced by visceral involvement, bone disease, or PSA
             elevation.

          5. Patients should meet the criteria of androgen independent prostate cancer (AIPC).
             Patients would fulfill these criteria if they continue to progress despite complete
             androgen blockade (surgical or medical castration with anti-androgen) and despite an
             anti-androgen withdrawal trial. Failing anti-androgen withdrawal is defined as no
             decline by 25% or more 3-weeks after stopping anti-androgens.

             Progression on hormonal therapy is defined as ANY of the following:

               -  PSA: 2 consecutive rising PSA values, at least 14-days apart, each being > 5
                  ng/ml

               -  For patients with visceral measurable disease, progression is defined as an
                  increase by 50% or more in the size of measurable areas, or any development of
                  new lesions.

               -  For patients with bone-only disease, progression is defined as the appearance of
                  2 or more new areas of abnormal uptake on a bone scan, when compared to prior
                  imaging studies. Changes in the uptake of already existing lesions will NOT be
                  used to define progressive disease.

               -  For patients with bone AND visceral disease, fulfilling any of the criteria in
                  5.2 or 5.3 is sufficient to define progression.

          6. Castration levels of testosterone (< 50 ng/dl) achieved via medical or surgical
             castration. Patients should continue on LHRH agonists throughout if this is the method
             used to achieve castration.

          7. Life expectancy of at least 6 months

          8. Adequate hematologic, renal, and liver function as evidenced by the following:

               -  WBC > 2000,

               -  ANC > 1000,

               -  Platelet count > 100,000,

               -  HgB > 9.0 g/dl, Creatinine < 2,

               -  Total bilirubin < 2x upper limit of normal,

               -  AST and ALT < 3 x upper limit of normal

          9. ECOG performance status of 0 or 1.

         10. The use of intravenous polyphosphates for bone metastases is allowed.

         11. upon completion of the taxotere portion of study, patient can be enrolled & receive
             GM-CSF if ANY of the following criteria is met:

               -  Patients received total of 8 cycles of taxotere & have no signs of disease
                  progression

               -  Patients achieved their maximal response despite receiving < than 8 cycles of
                  taxotere. Maximum response is defined as a drop in measures of PSA by 10% or less
                  on 2 consecutive measurements.

               -  Patients who have completed their chemotherapy < than 12 weeks prior to opening
                  this trial & still have stable disease without progression (by PSA and
                  radiographically) will be eligible to receive maintenance GM-CSF

        Exclusion Criteria:

          1. presence of brain metastases

          2. Known HIV+ status

          3. ECOG performance status of 2 or higher

          4. Use of investigational agents within 4 weeks of starting

          5. Patients with prior exposure to more than one chemotherapy program Patients who have
             received one chemotherapy schedule can be enrolled on study and receive GM-CSF (the
             maintenance arm) if their last chemotherapy was taxotere, given within the past 12
             weeks, and they have demonstrated NO evidence of progression radiographically and
             biochemically. Prior exposure to steroids is NOT an exclusion criteria.

          6. Patients with other active malignancies (excluding non-melanoma skin cancers)are
             excluded. Prior malignancies are not exclusion criteria as long as last treatment for
             such malignancies was over 5 years prior to enrollment.

          7. Treatment with investigational products are NOT an exclusion criteria, if therapy was
             last received over 4 weeks prior to enrollment.

          8. Any medical intervention or other condition which, in the opinion of the principle
             investigator, could compromise adherence with study requirements.