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: April 8, 2013
Last verified: April 2013
  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 2015
Estimated Primary Completion Date: December 2014 (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
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
  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: April 8, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014