Vaccine Therapy and 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 that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma.

Detailed Description
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OBJECTIVES: Determine the response rate (partial response or complete remission) in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase vaccine, and high-dose interleukin-2. Determine the immunologic response, measured by the reactivity of CD4+ and CD8+ T cells and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated with this regimen. OUTLINE: Patients receive vaccinia-tyrosinase vaccine intramuscularly (IM) on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29. Patients then receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose. Patients with stable disease or a minor, mixed, or partial response may receive additional courses of fowlpox-tyrosinase vaccine (2 doses) and IL-2 as above in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course beyond achieving CR. Patients are followed annually for at least 5 years. PROJECTED ACCRUAL: A total of 19-35 patients will be accrued for this study within 2 years.

Official Title
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Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: aldesleukin
* Biological: recombinant fowlpox-tyrosinase vaccine
* Biological: vaccinia-tyrosinase vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of metastatic melanoma Measurable disease Disease progression while receiving prior standard treatment No ocular or mucosal primary site No uncontrolled brain metastases PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-1 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 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome) AST/ALT less than 3 times normal Hepatitis B surface antigen negative Hepatitis C antibody negative Renal Creatinine no greater than 1.6 mg/dL Cardiovascular No major cardiovascular illness Pulmonary No major respiratory illness Immunologic HIV negative No autoimmune disease No active systemic infections No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation) No allergy to eggs No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No close contact with the following individuals for 2 weeks after vaccinia vaccination: Children under 5 years of age Pregnant women Individuals with prior or active eczema or other eczematoid skin disorders Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) Immunosuppressed individuals No active atopic dermatitis No prior or active eczema No active cases of the following conditions: Extensive psoriasis Severe acneiform rash Impetigo Varicella zoster Burns Traumatic or pruritic skin conditions Open wounds No unhealed surgical scars Healed surgical stomas (e.g., colostomy) allowed PRIOR CONCURRENT THERAPY: Biologic therapy No prior recombinant vaccinia or fowlpox vaccines for melanoma No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma Prior individual tyrosinase peptides are allowed No prior high-dose interleukin-2 Chemotherapy Not specified Endocrine therapy No concurrent oral, IV, topical, or inhaled steroids Radiotherapy Not specified Surgery Recovered from prior surgery Other Recovered from prior therapy for melanoma More than 3 weeks since prior systemic therapy for melanoma No other concurrent systemic therapy for melanoma

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: recombinant fowlpox-tyrosinase vaccine|nan|
|Biological: vaccinia-tyrosinase vaccine|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