Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020267
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-02
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Randomized Study of MAGE-12 Peptide Vaccine in Patients With Refractory Metastatic Cancer Expressing MAGE-12 Antigen
Status:
COMPLETED
Status Verified Date:
2024-03
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 peptide may make the body build an immune response and kill tumor cells
PURPOSE Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy
PURPOSE Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the toxicity profile of MAGE-12 peptide vaccine in patients with refractory metastatic cancer that expresses MAGE-12 antigen
II Determine whether an immunologic response as measured by an in vitro sensitization assay can be obtained after administration of this regimen in these patients
III Determine a frequency of administration for this regimen based on immunologic response in these patients
IV Determine other immunologic parameters in these patients treated with this regimen
V Determine the clinical response rate in these patients treated with this regimen
PROTOCOL OUTLINE This is a randomized study Patients are stratified according to disease metastatic cutaneous melanoma vs other tumor types Patients are randomized to one of two treatment arms
Arm I Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant subcutaneously SC weekly for 4 doses
Arm II Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant SC once every 3 weeks for 4 doses
Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours beginning on the day after each immunization and continuing for up to 4 days Patients achieving stable disease or a mixed partial or complete response continue on vaccine therapy alone for up to 24 total doses
Patients are followed at 3 weeks
PROJECTED ACCRUAL
A total of 26-56 patients 13-28 per treatment arm will be accrued for this study within 1 year
II Determine whether an immunologic response as measured by an in vitro sensitization assay can be obtained after administration of this regimen in these patients
III Determine a frequency of administration for this regimen based on immunologic response in these patients
IV Determine other immunologic parameters in these patients treated with this regimen
V Determine the clinical response rate in these patients treated with this regimen
PROTOCOL OUTLINE This is a randomized study Patients are stratified according to disease metastatic cutaneous melanoma vs other tumor types Patients are randomized to one of two treatment arms
Arm I Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant subcutaneously SC weekly for 4 doses
Arm II Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant SC once every 3 weeks for 4 doses
Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours beginning on the day after each immunization and continuing for up to 4 days Patients achieving stable disease or a mixed partial or complete response continue on vaccine therapy alone for up to 24 total doses
Patients are followed at 3 weeks
PROJECTED ACCRUAL
A total of 26-56 patients 13-28 per treatment arm will be accrued for this study within 1 year
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-1034 | None | None | None |
| NCI-00-C-0182 | None | None | None |