Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment

National Cancer Institute (NCI)

Overview

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's 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.

OBJECTIVES: * Determine the clinical responses in patients with HLA-A0201-positive refractory metastatic melanoma treated with tyrosinase-related protein-2:180-188 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-2):180-188 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-2:180-188 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-2:180-188 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Melanoma (Skin)

Interventions

aldesleukinBIOLOGICAL

incomplete Freund's adjuvantBIOLOGICAL

recombinant tyrosinase-related protein-2BIOLOGICAL

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Refractory to standard therapy * No resectable locoregional disease * HLA-A0201 positive * Measurable disease * Previously resected brain metastases, brain metastases stable after prior radiosurgery, or brain metastases less than 1 cm and without edema allowed 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 * No coagulation disorders Hepatic: * Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome) * AST/ALT less than 3 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No major medical illness of the cardiovascular system * No cardiac ischemia\* * No myocardial infarction\* * No cardiac arrhythmias\* NOTE: \* For interleukin-2 (IL-2) administration Pulmonary: * No major medical illness of the respiratory system * No obstructive or restrictive pulmonary disease (for IL-2 administration) Immunologic: * HIV negative * No primary or secondary immunodeficiency * No known immunodeficiency disease * No autoimmune disease * No active systemic infections Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy for melanoma * No prior immunization to tyrosinase-related protein-2 antigen * No other concurrent biologic therapy for melanoma Chemotherapy: * At least 3 weeks since prior chemotherapy for melanoma and recovered * No concurrent chemotherapy for melanoma Endocrine therapy: * At least 3 weeks since prior endocrine therapy for melanoma * No concurrent systemic steroid therapy * No concurrent endocrine therapy for melanoma Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy for melanoma and recovered * No concurrent radiotherapy for melanoma Surgery: * See Disease Characteristics Other: * No other concurrent therapy for melanoma

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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