Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b Followed by Cisplatin, Vinblastine and Dacarbazine for Patients With Melanoma or Malignancies Potentially Responsive to SSG and/or Interferons
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy
研究概览
简要总结
RATIONALE: Sodium stibogluconate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. Drugs used in chemotherapy, such as cisplatin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sodium stibogluconate and interferon alfa-2b together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon alfa-2b, cisplatin, vinblastine, and dacarbazine in treating patients with advanced melanoma or other cancer.
详细描述
OBJECTIVES:
Primary
- To determine the safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy.
- To confirm the activity of sodium stibogluconate in augmenting cytokine effects.
Secondary
- To quantify the effects of sodium stibogluconate on interferon alfa-2b induced gene modulation and signal transduction pathways by measuring the serum soluble gene products.
- To define the effectiveness of sodium stibogluconate in inhibiting the protein tyrosine phosphatases SHP-1 and SHP-2 assayed from peripheral blood leukocytes of patients receiving sodium stibogluconate in combination with interferon alfa-2b.
- To define the pharmacokinetics of sodium stibogluconate in serum at escalating doses.
- To assess clinical response to the combination of sodium stibogluconate and interferon alfa-2b as priming for combination chemotherapy.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
recombinant interferon alfa-2b
recombinant interferon alfa-2b
干预措施: recombinant interferon alfa-2b (Biological)
recombinant interferon alfa-2b
recombinant interferon alfa-2b
干预措施: cisplatin (Drug)
recombinant interferon alfa-2b
recombinant interferon alfa-2b
干预措施: sodium stibogluconate (Drug)
recombinant interferon alfa-2b
recombinant interferon alfa-2b
干预措施: dacarbazine (Drug)
recombinant interferon alfa-2b
recombinant interferon alfa-2b
干预措施: vinblastine (Drug)
结局指标
主要结局
Safety of the combination of sodium stibogluconate and interferon alfa-2b with chemotherapy
时间窗: 2 years
次要结局
- Effects of sodium stibogluconate on interferon alfa-2b induced gene modulation and signal transduction pathways by measuring the serum soluble gene product(2 years)
- Effectiveness of sodium stibogluconate in inhibiting the protein tyrosine phosphatases SHP-1 and SHP-2 assayed from peripheral blood leukocytes(2 years)
- Pharmacokinetics of sodium stibogluconate in serum at escalating doses(2 years)
- Clinical response to the combination of sodium stibogluconate and interferon alfa-2b as priming for combination chemotherapy(2 years)