Prostate Cancer
Conditions
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.
Interventions
DRUGGM-CSF
Each cycle will consist of 28 days. Patients will receive 250 ug/m2/day of GM-CSF administered subcutaneously on days 1-14.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA Response | Monthly |
Countries
United States
Outcome results
None listed