Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019994
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Vaccine Therapy 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 a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens
Status:
COMPLETED
Status Verified Date:
2003-03
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 may make the body build an immune response to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy
Detailed Description:
OBJECTIVES
Determine the clinical response to immunization using gp10044-59 antigen peptide plus gp100209-217 210M and MART-126-35 27L antigen peptides in patients with metastatic melanoma who are HLA-DRB10401 and HLA-A0201 positive
Determine the clinical response to immunization using gp10044-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB10401 positive but HLA-A0201 negative
Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment
Evaluate the toxicity profiles of these regimens in these patients
OUTLINE Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100209-217 210M antigen peptide immunization
Group 1 HLA-A0201 positive and no prior gp100209-217 210M antigen peptide Patients receive gp10044-59 and gp100209-217 210M antigen peptides emulsified together in Montanide ISA-51 ISA-51 subcutaneously SC and gp10044-59 and MART-126-35 27L antigen peptides emulsified together in ISA-51 SC
Group 2 HLA-A0201 positive and prior gp100209-217 210M antigen peptide Patients receive treatment as in group 1
Group 3 HLA-A0201 negative and no prior gp100209-217 210M antigen peptide Patients receive gp10044-59 antigen peptide emulsified in ISA-51 SC alone
All groups Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity Patients with complete response after 4 doses receive a maximum of 2 additional doses Patients with stable disease or minor mixed or partial response after 4 doses receive a maximum of 12 additional doses Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization
Patients are followed at 3-4 weeks
PROJECTED ACCRUAL A total of 45-75 patients 15-25 per immunization group will be accrued for this study within 2 years
Determine the clinical response to immunization using gp10044-59 antigen peptide plus gp100209-217 210M and MART-126-35 27L antigen peptides in patients with metastatic melanoma who are HLA-DRB10401 and HLA-A0201 positive
Determine the clinical response to immunization using gp10044-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB10401 positive but HLA-A0201 negative
Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment
Evaluate the toxicity profiles of these regimens in these patients
OUTLINE Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100209-217 210M antigen peptide immunization
Group 1 HLA-A0201 positive and no prior gp100209-217 210M antigen peptide Patients receive gp10044-59 and gp100209-217 210M antigen peptides emulsified together in Montanide ISA-51 ISA-51 subcutaneously SC and gp10044-59 and MART-126-35 27L antigen peptides emulsified together in ISA-51 SC
Group 2 HLA-A0201 positive and prior gp100209-217 210M antigen peptide Patients receive treatment as in group 1
Group 3 HLA-A0201 negative and no prior gp100209-217 210M antigen peptide Patients receive gp10044-59 antigen peptide emulsified in ISA-51 SC alone
All groups Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity Patients with complete response after 4 doses receive a maximum of 2 additional doses Patients with stable disease or minor mixed or partial response after 4 doses receive a maximum of 12 additional doses Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization
Patients are followed at 3-4 weeks
PROJECTED ACCRUAL A total of 45-75 patients 15-25 per immunization group will be accrued for this study within 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-T99-0079 | None | None | None |
| NCI-99-C-0159 | None | None | None |