Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002952
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
1999-11-01
Brief Title:
Vaccine Therapy and Interleukin-12 in Treating Patients With Metastatic Melanoma
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Phase III Study of Immunization With MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2013-09
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 tumor antigen gene may make the body build an immune response to kill tumor cells Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cell to kill melanoma cells Combining vaccine therapy with interleukin-12 may kill more melanoma cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy plus interleukin-12 in treating patients who have metastatic melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy plus interleukin-12 in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES I Determine the safety and maximum tolerated dose level of the vaccine consisting of MAGE-3 or Melan-A human tumor antigen genes peptide-pulsed autologous peripheral blood mononuclear cells plus interleukin-12 II Determine if the procedure results in successful immunization III Assess the response of the tumor to the vaccine
OUTLINE This is an open label nonrandomized single institution study Patients receive 3 initial courses of treatment consisting of 21 days each Treatment consists of an immunization with MAGE-3 or Melan-A peptide-loaded autologous PBMC and interleukin-12 IL-12 on the first day IL-12 on days 3 and 5 and 16 days of rest The first cohort is not administered IL-12 and the next cohorts are given escalating doses of IL-12 The Phase II dose will be one dose level below the MTD Patients who have a tumor remission response or stable disease may continue treatment for up to one year Phase I completed as of 041999 Patients are followed every 3 months
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study
OUTLINE This is an open label nonrandomized single institution study Patients receive 3 initial courses of treatment consisting of 21 days each Treatment consists of an immunization with MAGE-3 or Melan-A peptide-loaded autologous PBMC and interleukin-12 IL-12 on the first day IL-12 on days 3 and 5 and 16 days of rest The first cohort is not administered IL-12 and the next cohorts are given escalating doses of IL-12 The Phase II dose will be one dose level below the MTD Patients who have a tumor remission response or stable disease may continue treatment for up to one year Phase I completed as of 041999 Patients are followed every 3 months
PROJECTED ACCRUAL A total of 34 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 |
|---|---|---|---|
| NCI-G97-1162 | None | None | None |
| UCCRC-9018 | None | None | None |
| UCCRC-8381 | None | None | None |