Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015977
Status:
COMPLETED
Last Update Posted:
2014-03-07
First Post:
2001-05-06
Brief Title:
Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-03
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 Vaccines made from a patients white blood cells may make the body build an immune response to kill cancer cells Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill cancer cells Combining vaccine therapy with interleukin-12 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific T-cell priming in patients with metastatic hormone-refractory prostate cancer
Determine the clinical response in patients treated with this regimen
OUTLINE Patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously SC on day 1 and interleukin-12 SC on days 1 3 and 5 Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 37 weeks
Determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific T-cell priming in patients with metastatic hormone-refractory prostate cancer
Determine the clinical response in patients treated with this regimen
OUTLINE Patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously SC on day 1 and interleukin-12 SC on days 1 3 and 5 Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 37 weeks
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 |
|---|---|---|---|
| NCI-1192 | None | None | None |
| UCCRC-9845 | None | None | None |