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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sargramostim
immunohistochemistry staining method
immunological diagnostic method
laboratory biomarker analysis
conventional surgery
neoadjuvant therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GM-CSF before surgery

Arm Description

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

Outcomes

Primary Outcome Measures

Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2006
Last Updated
June 24, 2014
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00305669
Brief Title
GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GM-CSF before surgery
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
immunological diagnostic method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Fong, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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

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