Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma.
研究概览
简要总结
Primary Objectives:
- To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma.
- To determine if IFN alters the plasma pharmacokinetics of etoposide.
- To determine the toxicities of IFN and etoposide when administered together.
- To determine IFN blood levels following combination therapy.
详细描述
Interferon Alpha (IFN)- will be given as a shot under the skin. One hour later, VP-16 will be infused through a catheter (tube) placed in a vein over 3 hours. The drugs will be given daily for 5 days. The treatment will be repeated every 3 - 4 weeks for up to 24 - 32 weeks (8 courses). The catheter will remain in place throughout treatment.
Patients who are candidates for surgery will first receive two courses of treatment. If the tumor gets worse or if severe side effects occur, treatment will be stopped, and the tumor will be removed right away. If the tumor responds well (begins to shrink or does not get worse) and severe side effects do not occur, the patient will receive six more courses of treatment after surgery.
Patients who are not candidates for surgery will receive two initial courses of treatment. If the tumor responds well and severe side effects do not occur, the patient will receive six more courses of treatment.
The treatment will be given in the outpatient department. Before treatment begins, the patient will have a health examination. Blood tests, a urine test, and heart tests will be given. X-rays, computed tomography (CT) scans, and a bone scan will be done. The location and size of all lesions will be recorded.
During treatment, patients will have a blood test every week. Before each course, a health examination, a urine test, and chest x-ray will be given and the size of all measurable cancer will be recorded. After the second course, the CT and bone scans will be repeated. All the tests will be repeated at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed relapsed osteosarcoma who have failed standard chemotherapy.
- •Age 5-70 years.
- •Life expectancy of at least 12 weeks and a Zubrod performance status of less than or equal to
- •Patients must have measurable disease.
- •Adequate hematologic, coagulation, renal, and hepatic function.
- •No chemotherapy, immunotherapy, hormonal therapy or radiation therapy within 3 weeks of study entry.
排除标准
- •Patients who are likely to have significant systems because of rapidly progressive disease, ascites or hepatic metastasis.
- •Pregnant or lactating women.
- •Patients who have had more than one prior biologic response modifier.
- •Serious intercurrent illness, active infections, or central nervous system (CNS) disease.
- •Patients of childbearing potential, not practicing adequate contraception.
- •Significant cardiovascular disease.
研究组 & 干预措施
Interferon Alpha + Etoposide
Interferon Alpha 5x10^6 mu/m^2 subcutaneously and Etoposide 100 mg/m^2 intravenously, both daily for 5 days
干预措施: Etoposide (Drug)
Interferon Alpha + Etoposide
Interferon Alpha 5x10^6 mu/m^2 subcutaneously and Etoposide 100 mg/m^2 intravenously, both daily for 5 days
干预措施: Interferon Alpha (Drug)
结局指标
主要结局
Number of Patients with Response when combining IFN with etoposide for the treatment of relapsed osteosarcoma.
时间窗: Up to 24 - 32 weeks (8 courses of 3 - 4 weeks)
Complete Response (CR): Disappearance of all evidence of tumor for at least one cycle; Lytic or mixed bone lesions improved by scan or shown some ossification by x-ray; and free of all symptoms of cancer. Partial Response (PR): 50% or \> decrease in sum of product of diameters of all measured lesions persisting for at least one cycle or 4 weeks. No lesion may increase in size or new lesion appear. Minor Response (MR): Decrease in measurable lesion(s) too small or too brief to qualify as Partial Response.
次要结局
未报告次要终点