Patient case: 55-year-old male with Melanoma. Genetic variant: NRAS (Q61K). Other conditions: Hypertension.

Clinical trial: Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma

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.

Eligibility: 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

Relevance to patient case: not relevant