Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for Patients With Rising Prostate-Specific Antigen (PSA)

Study Overview
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Brief Summary
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This is a Phase II study to test the efficacy of exogenously administered GM-CSF in prostate cancer patients who have failed definitive local therapy, and have only serologic (PSA) evidence of progression.

Official Title
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A Phase II Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for the Treatment of Patients With Evidence of Serologic (PSA) Progression After Definitive Therapy for Localized Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: GM-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of adenocarcinoma of the prostate; stage T1-T3, N0-N1, M0 Prior definitive therapy for primary prostate cancer consisting of:external beam radiotherapy;brachytherapy with or without pelvic external beam radiation; or radical prostatectomy with or without adjuvant or salvage radiation therapy Therapeutic PSA response to primary therapy below 1.0 ng/ml post radiation therapy or below 0.4 ng/ml for radical prostatectomy Patients treated with adjuvant or salvage radiation therapy following radical prostatectomy are eligible provided:Post prostatectomy PSA was never > 6.0 ng/ml, last effective day of androgen deprivation is at least 3 months prior to study entry Recurrent PSA level elevation (between 0.4 ng/ml and 6.0 ng/ml) on two determinations at least one week apart. No clinical evidence of gross local recurrence or known metastatic disease other than PSA elevation. Transrectal ultrasound and/or biopsy to evaluate local recurrence is not required. All patients will receive a bone scan and CT scan of the abdomen to exclude metastases. Estimated life expectancy of at least 6 months. ECOG Performance status of 0 or 1. Willing and able to give informed consent. Exclusion Criteria: Cryosurgery as definitive therapy of primary tumor. Any metastasis. No concurrent or prior malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. Current systemic steroid therapy (inhaled or topical steroids acceptable). Prior hormonal therapy for treatment of progressive disease. Prior chemotherapy, immunotherapy, or therapy with other experimental agents for prostate cancer. Any surgery within the prior 4 weeks. Bilirubin and SGOT > 2 x upper limit of normal. BUN and serum creatinine > 2.0 times normal. No active congestive heart failure. If there is a history of clinically significant obstructive airway disease, a DLCO must exceed 50%. Active uncontrolled bacterial, viral or fungal infection until these conditions are corrected or controlled. Any underlying medical condition which in the principal investigator's opinion will make the administration of GM-CSF hazardous or obscure the interpretation of adverse events. PSA > 6.0 ng/ml
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)<br> | Drug: GM-CSF<br>* Each cycle will consist of 28 days. Patients will receive 250 ug/m2/day of GM-CSF administered subcutaneously on days 1-14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Response |  | Monthly |