Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019383
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 TRP1
Status:
COMPLETED
Status Verified Date:
2003-06
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 Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma
PURPOSE Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma
Detailed Description:
OBJECTIVES
Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen either alone or when combined with 1 of 3 adjuvants
Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients
OUTLINE Patients are stratified by HLA status A1 vs A3 vs A24 vs A31
Patients are assigned to 1 of 4 vaccine groups
Group 1 HLA-A1 positive Patients receive tyrosinase240-251
Group 2 HLA-A3 positive Patients receive gp10017-25 closed to accrual 5172000
Group 3 HLA-A24 positive Patients receive tyrosinase206-214
Group 4 HLA-A31 positive Patients receive tyrosinase related protein-1 Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants interleukin-2 IL-2 IV IL-2 delayed IV or sargramostim GM-CSF SQ depending on the time of entry into study and response to treatment
At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study If a second patient develops unacceptable toxicity that schedule of peptide administration is discontinued
Patients exhibiting stable minor mixed or partial response may receive up to 12 additional courses
Patients are followed for 4-6 weeks
PROJECTED ACCRUAL A maximum of 457 patients will be accrued for this study over 35 years
Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen either alone or when combined with 1 of 3 adjuvants
Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients
OUTLINE Patients are stratified by HLA status A1 vs A3 vs A24 vs A31
Patients are assigned to 1 of 4 vaccine groups
Group 1 HLA-A1 positive Patients receive tyrosinase240-251
Group 2 HLA-A3 positive Patients receive gp10017-25 closed to accrual 5172000
Group 3 HLA-A24 positive Patients receive tyrosinase206-214
Group 4 HLA-A31 positive Patients receive tyrosinase related protein-1 Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants interleukin-2 IL-2 IV IL-2 delayed IV or sargramostim GM-CSF SQ depending on the time of entry into study and response to treatment
At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study If a second patient develops unacceptable toxicity that schedule of peptide administration is discontinued
Patients exhibiting stable minor mixed or partial response may receive up to 12 additional courses
Patients are followed for 4-6 weeks
PROJECTED ACCRUAL A maximum of 457 patients will be accrued for this study over 35 years
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-98-C-0022 | None | None | None |
| NCI-T97-0088 | None | None | None |