Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients with metastatic melanoma that has not responded to previous treatment.

Detailed Description
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OBJECTIVES: I. Determine the clinical response of patients receiving DNA gp100 antigen alone or in combination with interleukin-2 for recurrent metastatic melanoma. II. Identify the immunologic response in these patients prior to and after these treatments. III. Determine the toxicity of these treatments in these patients. PROTOCOL OUTLINE: Patients are accrued for the first three cohorts and the study proceeds to the final two cohorts if responses are observed. Cohort I: Patients receive gp100 antigen intramuscularly (IM) into each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort II: Patients receive gp100 antigen intradermally (ID) at 5 sites on each of 2 proximal extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort III: Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for up to 4 doses. If patients do not exhibit immunologic response or dose-limiting toxicity, they may receive a higher dose of gp100 antigen on subsequent courses. Cohort IV: If cohorts I, II, or III do not produce an immune response and do not experience dose-limiting toxicity, patients receive a higher dose of gp100 antigen IM into each of 2 proximal extremities every 4 weeks for up to 4 doses. Cohort V: Patients receive gp100 antigen IM or ID at the dose found to produce immunization once every 4 weeks for up to 4 doses. Patients also receive interleukin-2 IV over 15 minutes every 8 hours for 5 days (15 doses), beginning within 24 hours after gp100 antigen. Patients with minor, mixed, or partial response or stable disease may receive additional courses of treatment following 3-4 weeks of rest. Patients receive a maximum of 12 courses. Patients are followed at 4-6 weeks. PROJECTED ACCRUAL: A maximum of 65 patients will be accrued for this study within 1 year.

Official Title
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Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma

Conditions
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Stage IV Melanoma, Recurrent Melanoma

Intervention / Treatment
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* Drug: gp100 antigen
* Drug: interleukin-2


Participation Criteria
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Eligibility Criteria
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PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of metastatic melanoma that has failed standard therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Prior surgery allowed --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0 or 1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL ALT/AST less than 2 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major respiratory disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No autoimmune disease No primary or secondary immunodeficiency HIV negative

Ages Eligible for Study
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Minimum Age: 16 Years


Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gp100 antigen|nan|
|Drug: interleukin-2|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage IV melanoma, stage, melanoma