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 may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

Detailed Description
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OBJECTIVES: Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2). Compare the immune response in patients before and after treatment with these regimens. Compare the toxicity profile of these regimens in these patients. OUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment cohorts. Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.) Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.) Cohort 3 (for patients in need of immediate interleukin-2 [IL-2] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. NOTE: *The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2 Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. Patients with responding disease may receive repeat vaccinations for up to 8 courses. Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3. Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy. PROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.

Official Title
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Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: aldesleukin
* Biological: fowlpox virus vaccine vector
* Biological: gp100 antigen


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven metastatic melanoma that has failed standard treatment Measurable disease HLA-A-201 positive PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC ≥ 3,000/mm^3 Platelet count ≥ 90,000/mm^3 No coagulation disorders Hepatic: Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) AST/ALT < 2 times normal Hepatitis B surface antigen negative Renal: Creatinine ≤ 2.0 mg/dL Cardiovascular: No major cardiovascular disease No cardiac ischemia by a stress thallium test or other comparable test* No myocardial infarction* No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2) Pulmonary: No major respiratory disease No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to receive IL-2 Immunologic: No autoimmune disease No known immunodeficiency disease No primary or secondary immunodeficiency No allergy to eggs No active systemic infections HIV negative Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No other active major medical illness* NOTE: *In order to be eligible to receive IL-2 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior gp100 vaccination Chemotherapy: Not specified Endocrine therapy: No concurrent steroids Radiotherapy: Not specified Surgery: Prior surgery for the malignancy allowed Other: At least 3 weeks since other prior therapy for the malignancy

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: fowlpox virus vaccine vector|nan|
|Biological: gp100 antigen|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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stage IV melanoma, recurrent melanoma