Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091338
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2004-09-07
Brief Title:
Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Study of Subcutaneous CYT 99 007 Interleukin-7 in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Interleukin-7 may stimulate a persons white blood cells to kill tumor cells Vaccines made from peptides may make the body build an immune response to kill tumor cells Combining interleukin-7 with vaccine therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of interleukin-7 IL-7 when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma
Determine the safety of this regimen in these patients
Secondary
Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients
Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen
Determine the antitumor effects of IL-7 in terms of a dose-escalation strategy in these patients
OUTLINE This is a dose-escalation study of interleukin-7 IL-7
Patients receive IL-7 subcutaneously SC on days 0 3 6 9 12 15 18 and 21 Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0 7 14 and 21 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity After the MTD is determined an additional 13 patients are treated at that dose level
Patients are followed at 1 2 and 5 weeks at 3 and 6 months and then at 1 year
PROJECTED ACCRUAL A total of 3-37 patients will be accrued for this study within 1-123 months
Primary
Determine the maximum tolerated dose of interleukin-7 IL-7 when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma
Determine the safety of this regimen in these patients
Secondary
Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients
Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen
Determine the antitumor effects of IL-7 in terms of a dose-escalation strategy in these patients
OUTLINE This is a dose-escalation study of interleukin-7 IL-7
Patients receive IL-7 subcutaneously SC on days 0 3 6 9 12 15 18 and 21 Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0 7 14 and 21 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity After the MTD is determined an additional 13 patients are treated at that dose level
Patients are followed at 1 2 and 5 weeks at 3 and 6 months and then at 1 year
PROJECTED ACCRUAL A total of 3-37 patients will be accrued for this study within 1-123 months
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-04-C-0235 | None | None | None |