NCT00019734已完成2 期
Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
适应症
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 to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Determine efficacy of recombinant fowlpox and vaccinia viruses encoding tyrosinase antigen, administered with or without low-dose interleukin-2 (IL-2), in terms of response, in patients with metastatic melanoma.
- Compare the response rate in patients to this vaccination administered with high-dose IL-2 to that in similar patients on previous trials treated with high-dose IL-2 alone.
- Determine the immunological response in patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms.
- Arm I: Patients receive recombinant fowlpox vaccine IM on day 1 followed 4 weeks later by recombinant vaccinia vaccine IM. Treatment repeats for a minimum of 4 vaccinations.
- Arm II: Patients receive vaccinations as in arm I plus low-dose interleukin-2 (IL-2) subcutaneously daily on days 2-13 after each vaccination.
- Arm III: Patients receive vaccinations as in arm I plus high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 after each vaccination.
Patients with stable disease or a minor, mixed, or partial response after four immunizations (1 course) may receive a second course of the same regimen beginning 4-6 weeks after the first course. After the second course, patients with tumor regression may continue to receive treatment in the absence of unacceptable toxicity until best response is achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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:
- •Histologically confirmed metastatic melanoma that has failed standard treatment
- •No ocular or mucosal melanoma as primary site
- •Measurable disease
- •No existing brain metastases
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •ECOG 0 or 1
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Platelet count at least 90,000/mm3
- •No coagulation disorder
- •Bilirubin no greater than 1.6 mg/dL
- •AST/ALT less than 3 times normal
- •Hepatitis B surface antigen 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 primary or secondary immunodeficiency
- •No allergy to eggs
- •No history of allergy or untoward reaction to prior smallpox vaccination
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Must be able to avoid close contact with children under 5 years, pregnant women, people with active or a past history of eczema or other eczematoid skin disorders, and immunosuppressed people for at least 2 weeks after each vaccinia virus vaccination
- •No active systemic infections
- •No active atopic dermatitis or active or past history of eczema
- •No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin conditions or open wounds
- •Surgical scars must be healed
- •Healed surgical stomas (e.g., colostomy) allowed
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior recombinant vaccinia or fowlpox vaccines for melanoma
- •At least 3 weeks since prior systemic biologic therapy for melanoma
- •Chemotherapy:
- •At least 3 weeks since prior systemic chemotherapy for melanoma
- •Endocrine therapy:
- •At least 3 weeks since prior systemic endocrine therapy for melanoma
- •No concurrent steroid therapy
- •Radiotherapy:
- •At least 3 weeks since prior systemic radiotherapy for melanoma
- •Prior surgery allowed
排除标准
- 未提供
研究者
研究点 (1)
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