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

NCT00678054 | Completed Phase 2 DMC

• 1 other identifier: UCSF99551
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PSA Response

  Monthly

Study Arms (1)

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

EXPERIMENTAL

Drug: GM-CSF

Interventions

GM-CSF DRUG

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

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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 12506177 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Eric Small, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: May 15, 2008
• Study Start: April 1, 1999
• Primary Completion: August 11, 2000
• Study Completion: October 23, 2015
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

US (1)