Spots Global Cancer Trial Database for Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous Treatment

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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