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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00678054
First received: February 20, 2008
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: GM-CSF
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • PSA Response [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 1999
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Drug: 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678054

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Eric Small, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00678054     History of Changes
Other Study ID Numbers: UCSF99551
Study First Received: February 20, 2008
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014