Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentages of the DLTEs
研究概览
简要总结
Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors
详细描述
PRIMARY OBJECTIVES:
I. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node metastatic tumors.
II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.
III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by intra-tumoral injection.
IV. To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed metastatic unresectable solid tumors
- •Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
- •No standard therapy available
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm for visceral lesions
- •At least 10 mm for cutaneous, subcutaneous, and nodal lesions
- •No untreated or edematous metastatic brain lesions
- •At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
- •No ascites or pleural effusions
- •No leptomeningeal disease
- •Performance status - ECOG 0-1
- •More than 3 months
- •Absolute granulocyte count at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •No bleeding diathesis
- •Bilirubin no greater than 1.5 mg/dL*
- •SGOT/SGPT no greater than 2 times upper limit of normal (ULN)*
- •Alkaline phosphatase no greater than 2 times ULN*
- •No elevated PT or PTT
- •No cirrhosis
- •No active hepatitis
- •No hepatic insufficiency
- •Creatinine no greater than 2.0 mg/dL
- •No renal insufficiency
- •No chronic obstructive pulmonary disorder
- •No active autoimmune disorders
- •No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis)
- •No significant allergy or hypersensitivity to eggs
- •No active seizure disorder
- •No active or chronic infections
- •No other significant medical disease that would preclude study participation
- •No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •More than 8 weeks since prior immunotherapy and recovered
- •More than 4 weeks since prior chemotherapy and recovered
- •At least 4 weeks since prior systemic corticosteroids
- •No concurrent corticosteroids
- •More than 2 weeks since prior radiotherapy and recovered
- •No evidence of bone marrow toxicity from prior radiotherapy
- •More than 4 weeks since prior surgery and recovered
排除标准
- 未提供
结局指标
主要结局
Percentages of the DLTEs
时间窗: 12 weeks
Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
次要结局
- Proportion of patients with any response (CR, PR, or SD)(12 weeks)
- Immune response(12 weeks)
- Change in quality of life, assessed using the FACT-G survey of emotional and functional well being(Baseline to 12 weeks)