Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022438
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-08-10
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 TRP-2
Status:
COMPLETED
Status Verified Date:
2004-07
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 Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic melanoma that has not responded to previous treatment
PURPOSE Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 to that of vaccine therapy alone in treating patients who have metastatic melanoma that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the clinical responses in patients with HLA-A0201-positive refractory metastatic melanoma treated with tyrosinase-related protein-2180-188 peptide vaccine alone
Determine the clinical response rate of patients who have an immediate need to receive interleukin-2 IL-2 in addition to this vaccine
Compare the immunologic response in terms of changes in T-cell precursors before and after treatment in patients treated with this vaccine with or without IL-2
Compare the toxicity profile of these regimens in these patients
OUTLINE This is a randomized open-label study
Patients who need immediate interleukin-2 IL-2 receive tyrosinase-related protein-2 TRP-2180-188 peptide vaccine emulsified with Montanide ISA-51 on day 1 and high-dose IL-2 IV over 15 minutes once every 8 hours on days 2-5 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients who do not need immediate IL-2 are randomized to 1 of 2 treatment arms
Arm I Patients receive TRP-2180-188 peptide vaccine emulsified with Montanide ISA-51 subcutaneously SC on day 1 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive TRP-2180-188 peptide vaccine emulsified with Montanide ISA-51 SC once weekly on weeks 1-4 Treatment repeats every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients who have a complete response CR receive 1 additional course after achieving CR Patients who have progressive disease while receiving vaccine alone may cross over to receive peptide vaccine with IL-2 for at least 2 courses
Patients are followed at 3 weeks
PROJECTED ACCRUAL A maximum of 83 patients 19-33 who need immediate interleukin-2 IL-2 15-25 per treatment arm who do not need immediate IL-2 will be accrued for this study within 1 year
Determine the clinical responses in patients with HLA-A0201-positive refractory metastatic melanoma treated with tyrosinase-related protein-2180-188 peptide vaccine alone
Determine the clinical response rate of patients who have an immediate need to receive interleukin-2 IL-2 in addition to this vaccine
Compare the immunologic response in terms of changes in T-cell precursors before and after treatment in patients treated with this vaccine with or without IL-2
Compare the toxicity profile of these regimens in these patients
OUTLINE This is a randomized open-label study
Patients who need immediate interleukin-2 IL-2 receive tyrosinase-related protein-2 TRP-2180-188 peptide vaccine emulsified with Montanide ISA-51 on day 1 and high-dose IL-2 IV over 15 minutes once every 8 hours on days 2-5 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients who do not need immediate IL-2 are randomized to 1 of 2 treatment arms
Arm I Patients receive TRP-2180-188 peptide vaccine emulsified with Montanide ISA-51 subcutaneously SC on day 1 Treatment repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive TRP-2180-188 peptide vaccine emulsified with Montanide ISA-51 SC once weekly on weeks 1-4 Treatment repeats every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients who have a complete response CR receive 1 additional course after achieving CR Patients who have progressive disease while receiving vaccine alone may cross over to receive peptide vaccine with IL-2 for at least 2 courses
Patients are followed at 3 weeks
PROJECTED ACCRUAL A maximum of 83 patients 19-33 who need immediate interleukin-2 IL-2 15-25 per treatment arm who do not need immediate IL-2 will be accrued for this study within 1 year
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-5369 | None | None | None |
| NCI-01-C-0193 | None | None | None |