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

2013年6月18日 更新者:National Cancer Institute (NCI)

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

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.

研究概览

详细说明

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.

研究类型

介入性

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 屏蔽:无(打开标签)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Suzanne L. Topalian, MD、NCI - Surgery Branch

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年1月1日

研究完成 (实际的)

2004年9月1日

研究注册日期

首次提交

2003年2月5日

首先提交符合 QC 标准的

2003年2月5日

首次发布 (估计)

2003年2月6日

研究记录更新

最后更新发布 (估计)

2013年6月19日

上次提交的符合 QC 标准的更新

2013年6月18日

最后验证

2004年7月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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