Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
|ClinicalTrials.gov Identifier: NCT00020397|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: NY-ESO-1 peptide vaccine Biological: aldesleukin||Phase 2|
- Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04 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-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only.
- Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients 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 Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen|
|Study Start Date :||November 2000|
|Study Completion Date :||July 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020397
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|