Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •16 and over
- •Performance status
- •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
- •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
- •Creatinine no greater than 1.6 mg/dL
- •Cardiovascular
- •No major cardiovascular illness
- •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)
- •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
- •Varicella zoster
- •Traumatic or pruritic skin conditions
- •Open wounds
- •No unhealed surgical scars
- •Healed surgical stomas (e.g., colostomy) allowed
- •PRIOR CONCURRENT THERAPY:
- 另有 15 项未显示
排除标准
- 未提供