Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00022438


Primary Contact:

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


Backup Contact:

N/A


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: September 20, 2017

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