Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00305669
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2006-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer
Sponsor:
University of California, San Francisco
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: