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

NCT ID: NCT00678054

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 2015-10-23

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

Group Type: EXPERIMENTAL

GM-CSF

Intervention Type: DRUG

Each cycle will consist of 28 days. Patients will receive 250 ug/m2/day of GM-CSF administered subcutaneously on days 1-14.

Interventions

GM-CSF

Each cycle will consist of 28 days. Patients will receive 250 ug/m2/day of GM-CSF administered subcutaneously on days 1-14.

Intervention Type: DRUG

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Small, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 12506177 (View on PubMed)

Other Identifiers

UCSF99551

Identifier Type: -

Identifier Source: org_study_id