Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021164
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunization of HLA-A0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
Status:
COMPLETED
Status Verified Date:
2004-04
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 II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer
PURPOSE Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer
Detailed Description:
OBJECTIVES
Determine whether an immunologic response can be obtained in HLA0201-expressing patients with metastatic cancer treated with telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51
Determine which vaccine strategy frequency schedule and dosing is best for future studies in these patients
Determine the toxicity of this treatment in these patients
Determine whether prior immunization with telomerase 540-548 peptide vaccine results in increased clinical response to interleukin-2 in patients with melanoma
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 three treatment arms
Arm I Patients receive telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 subcutaneously SC on day 1 of weeks 1-4 and 7-10 Patients also undergo leukapheresis over 3 hours at baseline and after each course of treatment
Arm II Patients receive telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on day 1 of weeks 1 4 7 and 10 Patients also undergo leukapheresis over 3 hours at baseline after the vaccine on week 4 and after each course of treatment
Arm III Patients receive telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on days 1-4 of weeks 1 4 7 and 10 Patients undergo leukapheresis as in arm II
Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 1 additional course of treatment after achieving CR
Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms may receive interleukin-2 IL-2 combined with vaccine as in arm II Beginning the day after each immunization IL-2 is administered IV over 15 minutes every 8 hours over 4 days on weeks 1 4 7 and 10 for a maximum of 12 doses Patients continuing to experience disease progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined therapy
Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 90-162 patients 30-54 per treatment arm 45-81 per stratum will be accrued for this study within less than 2 years
Determine whether an immunologic response can be obtained in HLA0201-expressing patients with metastatic cancer treated with telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51
Determine which vaccine strategy frequency schedule and dosing is best for future studies in these patients
Determine the toxicity of this treatment in these patients
Determine whether prior immunization with telomerase 540-548 peptide vaccine results in increased clinical response to interleukin-2 in patients with melanoma
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 three treatment arms
Arm I Patients receive telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 subcutaneously SC on day 1 of weeks 1-4 and 7-10 Patients also undergo leukapheresis over 3 hours at baseline and after each course of treatment
Arm II Patients receive telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on day 1 of weeks 1 4 7 and 10 Patients also undergo leukapheresis over 3 hours at baseline after the vaccine on week 4 and after each course of treatment
Arm III Patients receive telomerase 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on days 1-4 of weeks 1 4 7 and 10 Patients undergo leukapheresis as in arm II
Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 1 additional course of treatment after achieving CR
Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms may receive interleukin-2 IL-2 combined with vaccine as in arm II Beginning the day after each immunization IL-2 is administered IV over 15 minutes every 8 hours over 4 days on weeks 1 4 7 and 10 for a maximum of 12 doses Patients continuing to experience disease progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined therapy
Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 90-162 patients 30-54 per treatment arm 45-81 per stratum will be accrued for this study within less than 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-4970 | None | None | None |
| NCI-01-C-0176 | None | None | None |