GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305669
First received: March 21, 2006
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective treatment for localized prostate cancer.

PURPOSE: This clinical trial is studying how well giving GM-CSF before surgery works in treating patients with localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Biological: sargramostim
Other: immunohistochemistry staining method
Other: immunological diagnostic method
Other: laboratory biomarker analysis
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Two Dose Schedules of Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy. [ Time Frame: up to 6 weeks following surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: July 2006
Estimated Study Completion Date: June 2014
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
Biological: sargramostim Other: immunohistochemistry staining method Other: immunological diagnostic method Other: laboratory biomarker analysis Procedure: conventional surgery Procedure: neoadjuvant therapy

Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.
  • Determine whether tissue-specific antiprostate cancer immunity is induced by the administration of neoadjuvant GM-CSF in patients with localized prostate cancer prior to radical prostatectomy.

Secondary

  • Estimate the baseline antitumor immune response in patients treated with 2 different dose schedules of GM-CSF.
  • Determine the magnitude of the difference in immune response between 2 dose schedules of GM-CSF.
  • Determine the clinical effects, including prostate-specific antigen (PSA) decline, surgical outcome, surgical complications, and histologic appearance of surgical specimen, of this regimen in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to sargramostim (GM-CSF) dose.

Patients receive 1 of 2 dose levels of GM-CSF subcutaneously on days 1-14 or 1-21. Treatment continues in the absence of unacceptable toxicity. Within 3 days after the last dose of GM-CSF, patients undergo radical prostatectomy.

Blood is collected at baseline, day 28 of each course, and at the 4-week follow-up visit and is examined for activated T-cells. Tissue is collected during surgery and assessed for biomarkers and cytokines.

After completion of study treatment, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

    • No neuroendocrine or small cell features
  • No evidence of metastatic disease
  • Planning radical prostatectomy at least 2 months from now
  • Testosterone level normal

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • AST and ALT ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • PT and PTT normal
  • Fertile patients must use effective barrier contraception
  • No history of allergic reaction to compounds of similar chemical or biologic composition to sargramostim (GM-CSF)
  • No ongoing or active bacterial, viral, or fungal infection
  • DLCO > 50% if patient has a history of clinically significant obstructive airway disease
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No other active malignancy, defined as cancer for which therapy has been completed and patient is now considered < 30% risk of relapse, except nonmelanoma skin cancer
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No underlying medical condition that, in the opinion of the principal investigator, may make the administration of GM-CSF hazardous or obscure the interpretation of adverse events

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior major surgery
  • No prior radiotherapy, immunotherapy, chemotherapy, or other investigational therapy for this cancer
  • No prior hormonal therapy including any of the following:

    • Luteinizing-hormone releasing hormone (LHRH) agonists
    • LHRH antagonists
    • Antiandrogens, including any of the following:

      • Bilcalutamide
      • Flutamide
      • Nilutamide
    • 5-alpha-reductase inhibitors
    • PC-SPES or other PC-x product
    • Estrogen-containing nutriceuticals
  • No concurrent chemotherapy or radiotherapy
  • No concurrent systemic steroid therapy

    • Concurrent inhaled or topical steroids allowed
  • No other concurrent immunotherapy
  • No other concurrent investigational agent
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305669

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
Study Chair: Lawrence Fong, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00305669     History of Changes
Other Study ID Numbers: CDR0000455649, UCSF-04558, UCSF-H40568-25161-02B
Study First Received: March 21, 2006
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

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 17, 2014