A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.
详细描述
OBJECTIVES:
I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma.
II. Determine all clinical toxicities associated with this regimen in this patient population.
III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen.
V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases
- •Accessible for injection
- •Lesions must measure at least 1 cm
- •Patients with no prior treatment allowed
- •Patients must have one of the following as proof of prior vaccinia immunization:
- •Physician certification
- •Recollection and appropriate vaccination scar site
- •No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease
- •No ascites or pleural effusions
- •No leukemia or lymphoma
- •PATIENT CHARACTERISTICS:
- •Age: Over 18
- •Performance status: ECOG 0-1 Karnofsky 80-100%
- •Life expectancy: Greater than 3 months
- •WBC greater than 4,000/mm3
- •Platelet count greater than 100,000/mm3
- •Hemoglobin greater than 10g/dL
- •Bilirubin less than 1.5 mg/dL
- •Transaminases no greater than 2 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN
- •PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications
- •No alcoholic cirrhosis
- •Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min
- •No congestive heart failure
- •No serious cardiac arrhythmias
- •No recent prior myocardial infarction
- •No clinical coronary artery disease
- •No chronic obstructive pulmonary disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No seizure disorders
- •No underlying immunosuppressive disorder
- •No autoimmune disease HIV negative
- •No skin diseases
- •No open wounds
- •No eczema or other contraindications to vaccinia virus administration
- •Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment
- •No significant allergy or hypersensitivity to eggs
- •No active or chronic infections
- •No concurrent medical illness
- •No other significant medical disease which would increase risk to patient
- •No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma
- •PRIOR CONCURRENT THERAPY:
- •At least 8 weeks since prior immunotherapy and recovered
- •No prior live pox virus vector
- •No more than 2 prior chemotherapy regimens
- •At least 4 weeks since prior chemotherapy and recovered
- •At least 4 weeks since prior systemic corticosteroids
- 另有 7 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
干预措施: recombinant vaccinia-B7.1 vaccine (Biological)