Expired Study
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San Francisco, California 94115


Purpose:

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.


Criteria:

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


NCT ID:

NCT00678054


Primary Contact:

Principal Investigator
Eric Small, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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