Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

Phase 2CompletedNCT00020397

National Cancer Institute (NCI)

Overview

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.

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-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

Purpose

TREATMENT

Masking

NONE

Conditions

Melanoma (Skin)

Interventions

NY-ESO-1 peptide vaccineBIOLOGICAL

aldesleukinBIOLOGICAL

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma that expresses ESO-1 antigen * Must have progressed during prior standard treatment * Measurable or evaluable disease * HLA-A\*201 or HLA-DPB1\*04 positive PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 Hepatic: * SGOT and SGPT less than 3 times normal * Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No cardiac ischemia\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \*For interleukin-2 (IL-2) administration Pulmonary: * No obstructive or restrictive pulmonary disease (for IL-2 administration) Immunologic: * No autoimmune disease * No active primary or secondary immunodeficiency * HIV negative * No active systemic infections Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No other active major medical illness (for IL-2 administration) PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior ESO-1 immunization Chemotherapy: * Recovered from any prior chemotherapy Endocrine therapy: * No concurrent systemic steroid therapy Radiotherapy: * Recovered from any prior radiotherapy Surgery: * Not specified Other: * At least 3 weeks since any prior systemic therapy for cancer * No other concurrent systemic therapy for cancer

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.