NCT00019669已完成2 期
Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma.
PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2).
- Compare the immune response in patients before and after treatment with these regimens.
- Compare the toxicity profile of these regimens in these patients.
OUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment cohorts.
- Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.)
- Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.)
- Cohort 3 (for patients in need of immediate interleukin-2 [IL-2] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine.
NOTE: *The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2
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:
- •Histologically proven metastatic melanoma that has failed standard treatment
- •Measurable disease
- •HLA-A-201 positive
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 90,000/mm^3
- •No coagulation disorders
- •Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
- •AST/ALT < 2 times normal
- •Hepatitis B surface antigen negative
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular:
- •No major cardiovascular disease
- •No cardiac ischemia by a stress thallium test or other comparable test*
- •No myocardial infarction*
- •No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2)
- •No major respiratory disease
- •No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to receive IL-2
- •Immunologic:
- •No autoimmune disease
- •No known immunodeficiency disease
- •No primary or secondary immunodeficiency
- •No allergy to eggs
- •No active systemic infections
- •HIV negative
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other active major medical illness* NOTE: *In order to be eligible to receive IL-2
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior gp100 vaccination
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent steroids
- •Radiotherapy:
- •Not specified
- •Prior surgery for the malignancy allowed
- •At least 3 weeks since other prior therapy for the malignancy
排除标准
- 未提供
研究者
研究点 (2)
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