Clinical trial NCT00678054: Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for Patients With Rising Prostate-Specific Antigen (PSA)
Official title: A Phase II Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) for the Treatment of Patients With Evidence of Serologic (PSA) Progression After Definitive Therapy for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: PSA Response
timeFrame: Monthly
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Eric Small, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rini BI, Weinberg V, Bok R, Small EJ. Prostate-specific antigen kinetics as a measure of the biologic effect of granulocyte-macrophage colony-stimulating factor in patients with serologic progression of prostate cancer. J Clin Oncol. 2003 Jan 1;21(1):99-105. doi: 10.1200/JCO.2003.04.163.