NCT00036816终止3 期
Randomized Phase III Study Of Adjuvant Immunization With The NA17.A2 And Melanoma Differentiation Peptites In HLA-A2 Patients With Primary Ocular Melanoma At High Risk Of Relapse
European Organisation for Research and Treatment of Cancer - EORTC4 个研究点 分布在 2 个国家目标入组 13 人开始时间: 2002年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye.
PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.
详细描述
OBJECTIVES:
- Determine whether adjuvant NA17-A and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in HLA-A2-positive patients with primary ocular melanoma at high risk of relapse.
- Determine whether this regimen increases survival of these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vaccination with NA17-A and melanoma differentiation peptides (e.g., tyrosinase, Melan-A, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. Patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years.
- Arm II: Patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years.
All patients are followed every 3 months for 1 year and then every 6 months thereafter.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of ocular melanoma
- •No melanoma of the iris
- •Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy
- •No more than 5 weeks since the beginning of primary tumor treatment
- •Measurable disease
- •At least 12.0 mm in largest diameter OR
- •At least 6.0 mm in height
- •HLA-A2 positive
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 9 g/dL
- •Neutrophil count at least 2,000/mm^3
- •Lymphocyte count at least 700/mm^3
- •Platelet count at least 100,000/mm^3
- •No bleeding disorder
- •Bilirubin no greater than 2.0 mg/dL
- •AST and ALT no greater than 2 times upper limit of normal (ULN)
- •Lactate dehydrogenase no greater than 2 times ULN
- •Alkaline phosphatase no greater than 2 times ULN
- •Gamma glutamyl transpeptidases no greater than 2 times ULN
- •Hepatitis C antibody negative
- •Hepatitis B antigen negative
- •Creatinine no greater than 2.0 mg/dL
- •Immunologic:
- •No clinical immunodeficiency
- •No autoimmune diseases
- •No inflammatory bowel disease
- •No active infection requiring antibiotics
- •No multiple sclerosis
- •HIV negative
- •No other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- •No other uncontrolled illness
- •No psychological, familial, sociological, or geographical conditions that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No other concurrent immunotherapy or biologic therapy
- •Chemotherapy:
- •No concurrent chemotherapy
- •Endocrine therapy:
- •At least 3 weeks since prior steroids
- •No concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day)
- •Concurrent topical or inhalation steroids allowed
- 另有 17 项未显示
排除标准
- 未提供
研究者
研究点 (4)
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