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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305669
• Other study ID #: CDR0000455649
• Secondary ID: UCSF-04558UCSF-H
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2006
• Last updated: June 24, 2014
• Start date: July 2006
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• sargramostim

Other:
• immunohistochemistry staining method

• immunological diagnostic method

• laboratory biomarker analysis

Procedure:
• conventional surgery

• neoadjuvant therapy

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.		up to 6 weeks following surgery	Yes