Expired Study
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Bethesda, Maryland 20892


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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