NCT00022568Unknown1 期
A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
Herbert Irving Comprehensive Cancer Center1 个研究点 分布在 1 个国家开始时间: 2001年8月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 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.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma.
- Determine the clinical toxic effects of this vaccine in these patients.
- Determine the safety of this vaccine in these patients.
- Determine the clinical response of these patients to this vaccine.
- Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3 vaccinations. Patients with stable or responding disease may receive an additional course of vaccinations.
Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 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:
- •Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma
- •Lesion(s) must be accessible to percutaneous injection
- •Measurable lesion(s)
- •At least 1.0 cm
- •Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed
- •At least 6 weeks since prior definitive therapy (surgery or radiotherapy)
- •No untreated or edematous metastatic brain lesions or leptomeningeal disease
- •No ascites or pleural effusions
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Platelet count at least 100,000/mm3
- •Absolute granulocyte count at least 3,000/mm3
- •Hemoglobin at least 10 g/dL
- •Direct bilirubin no greater than 1.5 mg/dL
- •Transaminases no greater than 2 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN
- •No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications)
- •No hepatic insufficiency
- •No alcoholic cirrhosis
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •No renal insufficiency
- •Cardiovascular:
- •No congestive heart failure
- •No serious cardiac arrhythmias
- •No evidence of recent prior myocardial infarction on EKG
- •No clinical coronary artery disease
- •No chronic obstructive pulmonary disease
- •Immunologic:
- •No prior eczema
- •HIV negative
- •No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds)
- •No clinical or laboratory evidence of an underlying immunosuppressive disorder
- •No active or chronic infections
- •No significant allergy or hypersensitivity to eggs
- •No active seizure disorders
- •No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free
- •No evidence of bone marrow toxicity
- •No other concurrent medical illness that would preclude study
- •No other contraindications to vaccinia virus administration
- •No encephalitis
- •Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
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排除标准
- 未提供
研究者
研究点 (1)
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