Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019721
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
Status:
COMPLETED
Status Verified Date:
2002-08
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 may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma
PURPOSE Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy
PURPOSE Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy
Detailed Description:
OBJECTIVES
Compare the efficacy of gp100209-217210M peptide and MART-126-3527L peptide administered with or without high-dose interleukin-2 IL-2 in patients with metastatic melanoma who are HLA-A0201 positive
Determine the efficacy of these peptides in patients who cannot receive IL-2
Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2
Determine the efficacy of MART-126-3527L peptide in patients who have received prior gp100 antigen
Compare the immunologic response experienced by patients who have received peptide with or without IL-2 as measured by changes in T-cell precursors from before to after treatment
Compare the toxic effects of these regimens in these patients
OUTLINE This is a partially randomized study
Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy
Group A eligible to receive interleukin-2 IL-2 but not in immediate need no prior immunization with gp100 or MART-1 antigen Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 ISA-51 subcutaneously SC on day 1 Arm I closed as of 103002
Arm II Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 for up to 12 doses Arm II closed as of 103002
Group B ineligible to receive IL-2 due to other debilitating disease Patients receive treatment as in group A arm I
Group C need immediate IL-2 therapy due to extensive and rapid progression of disease Patients receive treatment as in group A arm II Group C closed as of 103002
Group D prior immunization with gp100 antigen Patients receive modified MART-126-3527L peptide emulsified in ISA-51 SC on day 1
Treatment in all groups repeats every 3 weeks for 4 courses Patients who achieve a minor mixed or partial response may receive up to 12 additional courses Patients who achieve complete response receive 2 additional courses
Patients are followed at 4-6 weeks
PROJECTED ACCRUAL A total of 103 patients 15-25 for group A arm I 19-33 for group A arm II and 15 each for groups B C and D will be accrued for this study within 1 year
Compare the efficacy of gp100209-217210M peptide and MART-126-3527L peptide administered with or without high-dose interleukin-2 IL-2 in patients with metastatic melanoma who are HLA-A0201 positive
Determine the efficacy of these peptides in patients who cannot receive IL-2
Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2
Determine the efficacy of MART-126-3527L peptide in patients who have received prior gp100 antigen
Compare the immunologic response experienced by patients who have received peptide with or without IL-2 as measured by changes in T-cell precursors from before to after treatment
Compare the toxic effects of these regimens in these patients
OUTLINE This is a partially randomized study
Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy
Group A eligible to receive interleukin-2 IL-2 but not in immediate need no prior immunization with gp100 or MART-1 antigen Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 ISA-51 subcutaneously SC on day 1 Arm I closed as of 103002
Arm II Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 for up to 12 doses Arm II closed as of 103002
Group B ineligible to receive IL-2 due to other debilitating disease Patients receive treatment as in group A arm I
Group C need immediate IL-2 therapy due to extensive and rapid progression of disease Patients receive treatment as in group A arm II Group C closed as of 103002
Group D prior immunization with gp100 antigen Patients receive modified MART-126-3527L peptide emulsified in ISA-51 SC on day 1
Treatment in all groups repeats every 3 weeks for 4 courses Patients who achieve a minor mixed or partial response may receive up to 12 additional courses Patients who achieve complete response receive 2 additional courses
Patients are followed at 4-6 weeks
PROJECTED ACCRUAL A total of 103 patients 15-25 for group A arm I 19-33 for group A arm II and 15 each for groups B C and D 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-T99-0033 | None | None | None |
| NCI-99-C-0092 | None | None | None |