A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
研究概览
简要总结
Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II.
Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.
Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.
详细描述
Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB) will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion. One arm of the study will be a standard 60 minute perfusion with melphalan as a single agent. The second arm of the study will combine melphalan, tumor necrosis factor, and interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100% response rates in a Phase II European trial. Patients will be followed for local response rates, duration of response, treatment toxicity, and disease-free survival.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Biopsy-proven Stage IIIA or IIIAB melanoma (M.D. Anderson staging system) of an extremity, as follows:
- •Advanced local disease indicated by 2 or more satellite or in-transit metastases.
- •Lower limb regional metastases must be distal to the apex of the femoral triangle except inguinal lymph node metastases.
- •Upper limb regional metastases must be distal to the deltoid insertion except axillary lymph node metastases.
- •No evidence of systemic disease outside the involved extremity.
- •Recurrent disease subsequent to prior successful limb perfusion allowed.
- •Bidimensional directly measurable dermal or subcutaneous lesion required.
- •PRIOR/CONCURRENT THERAPY:
- •No prior isolated limb perfusion.
- •Biologic Therapy: At least 1 month since Biologic Therapy.
- •At least 3 months since regional therapy of the extremity.
- •Chemotherapy: At least 1 month since chemotherap.y
- •At least 3 months since regional therapy of the extremity.
- •Endocrine Therapy: Not specified.
- •Radiotherapy: At least 1 month since radiotherapy.
- •Surgery: Not specified.
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over.
- •Performance status: ECOG 0 or
- •Hematopoietic: Platelets greater than 150,
- •Hepatic: Bilirubin less than 1.5 mg/dl; Coagulation profile normal.
- •Renal: Creatinine less than 2.0 mg/dl.
- •Cardiovascular: No evidence of peripheral vascular disease, e.g.:
- •No history of claudication.
- •HIV negative.
- •No pregnant or nursing women.
排除标准
- 未提供