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

June 24, 2014 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: laboratory biomarker analysis
Procedure: neoadjuvant therapy
Procedure: conventional surgery
Other: immunohistochemistry staining method
Biological: sargramostim
Other: immunological diagnostic method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 6 weeks following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000455649
  • UCSF-04558
  • UCSF-H40568-25161-02B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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