Phase II Randomized Study of Isolated Limb Perfusion Using Melphalan With or Without Tumor Necrosis Factor in Patients With Unresectable High Grade Soft Tissue Sarcomas of the Extremity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing melphalan directly to the tumor may kill more tumor cells and cause less damage to healthy tissues. It is not yet known whether melphalan plus tumor necrosis factor is more effective than melphalan alone for soft tissue sarcoma.
PURPOSE: Randomized phase II trial to study the effectiveness of isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have soft tissue sarcoma of the arm or leg.
详细描述
OBJECTIVES: I. Determine the response rates, duration of response, patterns of recurrence and overall survival in patients with unresectable high grade soft tissue sarcomas of the extremity following isolated limb perfusion (ILP) using melphalan with or without tumor necrosis factor (TNF).
II. Determine the application of these regimens as neoadjuvant therapy to render an unresectable sarcoma resectable.
III. Determine whether either regimen results in durable disease control and limb salvage for patients with multifocal unresectable high grade soft tissue sarcoma of the extremity or patients with stage IV soft tissue sarcoma with symptomatic primary extremity tumor.
PROTOCOL OUTLINE: This is a randomized study.
Patients are randomized to 1 of 2 treatment arms:
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics-- Histologically or cytologically proven unresectable high grade soft tissue sarcoma of the extremity Measurable disease All disease must be distal to the apex of the femoral triangle in the lower limb and distal to the deltoid insertion in the upper limb Must have no local resection option according to the consensus of staff surgeons and require amputation or resection of major nerves or vascular structures to control disease Metastatic disease allowed if patient would benefit from palliative treatment of primary tumor No prior limb perfusion No newly diagnosed pediatric sarcomas that have curative potential with other chemotherapeutic regimens (i.e., newly diagnosed Ewing's sarcoma, rhabdomyosarcoma, etc.) --Prior/Concurrent Therapy-- Biologic therapy: At least 1 month since prior biologic therapy and recovered Chemotherapy: No prior melphalan At least 1 month since other prior chemotherapy and recovered No more than 1 prior systemic chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 1 month since prior radiotherapy and recovered Surgery: Not specified Other: No concurrent immunosuppressive drugs or chronic anticoagulants that cannot be temporarily discontinued --Patient Characteristics-- Age: 15 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count greater than 100,000/mm3 Coagulation studies within 1 second of normal Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No severe peripheral vascular disease (no prior claudication or other ischemic peripheral vascular manifestations) Other: Weight greater than 30 kg Not pregnant or nursing Negative pregnancy test No active infection HIV negative
排除标准
- 未提供