Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
研究概览
地位
详细说明
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.
SECONDARY OBJECTIVES:
I. To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients with cutaneous tumors and visceral tumors.
II. To evaluate the quality of life during vaccine administration.
OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rF-B7.1 vaccine intratumorally on day 1.
ARM II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses.
Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment.
Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy.
Patients are followed every 3 months.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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New York
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New York、New York、美国、10029
- Mount Sinai Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Arm I (recombinant fowlpox-B7.1 vaccine)
Patients receive rF-B7.1 vaccine intratumorally on day 1.
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相关研究
辅助研究
其他名称：
Given intratumorally
其他名称：
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实验性的：Arm II (recombinant fowlpox-TRICOM vaccine)
Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
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相关研究
辅助研究
其他名称：
瘤内给药
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentages of the DLTEs
大体时间：12 weeks
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Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of patients with any response (CR, PR, or SD)
大体时间：12 weeks
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First, the proportion with any response (CR, PR or SD) will be compared to those with no response (PD).
Secondly, the proportion of any response (CR, PR or SD) compared to no response (PD) will be compared between the two treatment arms.
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12 weeks
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Immune response
大体时间：12 weeks
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Number of T-cells after treatment compared to those measured at baseline, and difference calculated as after-treatment minus baseline.
First comparison includes all subjects who completed treatment.
Mean change in T-Cells (final-baseline) tested against 0 with 2-tailed, 1-sample t-test, with alpha=.05.
Second analysis compares mean change in T-Cells between arms.
Performed as a 2-tailed, 2 independent samples t-test, with alpha=.05.
Third comparison is a sub-set analysis of patients with melanoma.
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12 weeks
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Change in quality of life, assessed using the FACT-G survey of emotional and functional well being
大体时间：Baseline to 12 weeks
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A mean observed change in the FACT-G score will be tested against 0 (no change) for the group as a whole.
Secondly, the change in score will be compared between the two treatment arms.
The overall mean change will also be compared to historical controls either from the literature for cancer patients or to the values for non-subject cancer patients receiving other therapies.
Comparisons will be by t-test if the sample distribution meets parametric assumptions.
If not non-parametric procedures will be used.
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Baseline to 12 weeks
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合作者和调查者
调查人员
- 首席研究员：Howard Kaufman、Icahn School of Medicine at Mount Sinai
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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