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

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: GM-CSF

Study type

Interventional

Funder types

Other

Identifiers

NCT00678054

UCSF99551

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Male

Volunteers

No Healthy Volunteers

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