Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00054535


Primary Contact:

Study Chair
Suzanne L. Topalian, MD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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