Status:
COMPLETED
Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for Patients With Rising Prostate-Specific Antigen (PSA)
Lead Sponsor:
University of California, San Francisco
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
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 progres...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00678054
Start Date
April 1 1999
End Date
October 23 2015
Last Update
August 23 2017
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115