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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305669
First received: March 21, 2006
Last updated: June 24, 2014
Last verified: June 2014
  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 ]

Enrollment: 24
Study Start Date: July 2006
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
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: 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: June 24, 2014
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014