Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
Brief summary
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
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.
Interventions
BIOLOGICALaldesleukin
BIOLOGICALrecombinant fowlpox-tyrosinase vaccine
BIOLOGICALvaccinia-tyrosinase vaccine
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed