Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020397
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunization Of HLA-A0201 or HLA-DPB104 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
Status:
COMPLETED
Status Verified Date:
2005-01
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 Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma
PURPOSE Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma
Detailed Description:
OBJECTIVES
Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I II or both peptides in HLA-A201 or HLA-DPB104 positive patients with refractory metastatic melanoma expressing ESO-1
Determine the toxicity of this vaccine in these patients
Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2
OUTLINE Patients are assigned to 1 of 3 groups according to HLA type
Group 1 HLA-A201 and HLA-DPB104 positive Patients receive ESO-1 peptide vaccine comprising class I ESO-1157-165 165V and class II ESO-1161-180 peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Group 2 HLA-A201 positive and HLA-DPB104 negativePatients receive ESO-1 peptide vaccine as in group I comprising class I peptide only
Group 3 HLA-A201 negative and HLA-DPB104 positivePatients receive ESO-1 peptide vaccine as in group I comprising class II peptide only
Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin IL-2 IV over 15 minutes every 8 hours for up to 4 days maximum of 12 doses Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression after at least 2 courses or unacceptable toxicity
Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment
Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 45-90 patients 15-30 per treatment group will be accrued for this study within 1 year
Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I II or both peptides in HLA-A201 or HLA-DPB104 positive patients with refractory metastatic melanoma expressing ESO-1
Determine the toxicity of this vaccine in these patients
Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2
OUTLINE Patients are assigned to 1 of 3 groups according to HLA type
Group 1 HLA-A201 and HLA-DPB104 positive Patients receive ESO-1 peptide vaccine comprising class I ESO-1157-165 165V and class II ESO-1161-180 peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Group 2 HLA-A201 positive and HLA-DPB104 negativePatients receive ESO-1 peptide vaccine as in group I comprising class I peptide only
Group 3 HLA-A201 negative and HLA-DPB104 positivePatients receive ESO-1 peptide vaccine as in group I comprising class II peptide only
Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin IL-2 IV over 15 minutes every 8 hours for up to 4 days maximum of 12 doses Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression after at least 2 courses or unacceptable toxicity
Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment
Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 45-90 patients 15-30 per treatment group 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-2390 | None | None | None |
| NCI-01-C-0032 | None | None | None |