Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for Patients With Rising Prostate-Specific Antigen (PSA)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
|
Drug: GM-CSF
Each cycle will consist of 28 days. Patients will receive 250 ug/m2/day of GM-CSF administered subcutaneously on days 1-14.
|
Outcome Measures
Primary Outcome Measures
- PSA Response [Monthly]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologic diagnosis of adenocarcinoma of the prostate; stage T1-T3, N0-N1, M0
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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
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Therapeutic PSA response to primary therapy below 1.0 ng/ml post radiation therapy or below 0.4 ng/ml for radical prostatectomy
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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
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Recurrent PSA level elevation (between 0.4 ng/ml and 6.0 ng/ml) on two determinations at least one week apart.
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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.
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Estimated life expectancy of at least 6 months.
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ECOG Performance status of 0 or 1.
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Willing and able to give informed consent.
Exclusion Criteria:
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Cryosurgery as definitive therapy of primary tumor.
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Any metastasis.
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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.
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Current systemic steroid therapy (inhaled or topical steroids acceptable).
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Prior hormonal therapy for treatment of progressive disease.
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Prior chemotherapy, immunotherapy, or therapy with other experimental agents for prostate cancer.
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Any surgery within the prior 4 weeks.
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Bilirubin and SGOT > 2 x upper limit of normal.
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BUN and serum creatinine > 2.0 times normal.
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No active congestive heart failure.
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If there is a history of clinically significant obstructive airway disease, a DLCO must exceed 50%.
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Active uncontrolled bacterial, viral or fungal infection until these conditions are corrected or controlled.
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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.
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PSA > 6.0 ng/ml
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
Sponsors and Collaborators
- University of California, San Francisco
Investigators
- Principal Investigator: Eric Small, MD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UCSF99551