Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305669
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2006-03-21
Brief Title:
GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-H40568-25161-02B | None | None | None |
| UCSF-04558 | None | None | None |