Phase I Combined Modality Protocol for Malignant Mesothelioma: Cisplatin & rIFN-alpha-2b Followed by Surgical Resection (Debulking), and Post-Op Concurrent Chemoradiotherapy With Cisplatin, +/- rIFN-alpha-2b
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 6
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy, radiation therapy, and interferon alfa may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of cisplatin plus interferon alfa followed by surgery and interferon alfa plus radiation therapy in treating patients with malignant pleural mesothelioma.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of neoadjuvant interferon alfa 2b (IFN-A2b) administered with cisplatin in patients with malignant pleural mesothelioma. II. Determine the MTD of IFN-A2b administered with radiation therapy and cisplatin after surgery in these patients. III. Determine the response rate and toxicity of induction therapy with IFN-A2b and cisplatin in these patients. IV. Determine the toxicity of concurrent radiation therapy, cisplatin, and IFN-A2b after surgery in these patients. V. Determine the local control rate, freedom from progression, median survival, and long term survival of these patients after combined modality therapy.
OUTLINE: This is a dose escalation study. Patients receive induction therapy consisting of cisplatin IV weekly and interferon alfa 2b (IFN-A2b) subcutaneously three times a week for 6 weeks. Patients who experience at least 25% tumor shrinkage receive another 4 weeks of therapy. Patients then undergo debulking surgery to remove all gross tumor, if possible. If this resection is performed, then patients begin radiation therapy 2-6 weeks after surgery. Patients with unresectable tumors begin radiation therapy 2-4 weeks after the last course of induction chemotherapy. Patients undergo radiation therapy 5 days a week for 6 weeks. Concurrently, patients receive cisplatin IV weekly and IFN-A2b subcutaneously three times a week. Cohorts of 4 patients each receive escalated doses of IFN-A2b during induction chemotherapy. Once the maximum tolerated dose (MTD) of IFN-A2b is established, one dose level below this dose is used for the beginning doses of IFN-A2b during adjuvant chemotherapy. If no unacceptable toxic effects occur, then the dose of IFN-A2b is escalated to the induction MTD. Patients are followed at 3-6 weeks after completing radiochemotherapy, then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2-3 years.
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
- •DISEASE CHARACTERISTICS:
- •Histologically proven ipsilateral malignant pleural mesothelioma
- •No contralateral thoracic or intra-abdominal involvement
- •No distant metastases
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over
- •Performance status: ECOG 0 or 1
- •Life expectancy: Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 2,000/mm3
- •Platelet count greater than 100,000/mm3
- •No symptomatic anemia requiring transfusion
- •Bilirubin less than 2.0 mg/dL
- •No autoimmune hepatitis
- •No history of decompensated liver disease; e.g. esophageal varices
- •Albumin at least 2.5 mg/dL
- •Increasing prothrombin time of at least 2.0
- •Renal: Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No symptomatic or debilitating cardiovascular disease,
- •No concurrent thrombophlebitic or embolic disorders
- •Pulmonary:
- •No symptomatic or debilitating pulmonary disease,
- •Pretreatment diffusion capacity greater than 30% of predicted normal
- •Projected post-treatment FEV1 at least 1.0 L
- •No prior malignancy within 3 years, except nonmelanomatous skin cancer
- •Carcinoma in situ of the cervix
- •Ductal carcinoma in situ of the breast
- •Not pregnant
- •Fertile patients must use effective contraception
- •No history of hypersensitivity to interferon or any component of the injection
- •No uncontrolled diabetes (blood sugars consistently at least 300 mg/dL)
- •No insulin dependent diabetes mellitus with history of ketoacidosis within 1 year
- •No psychosis
- •No uncontrolled thyroid abnormalities
- •No active infection requiring intravenous antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy: No prior biologic therapy
- •Chemotherapy: No prior chemotherapy
- •Endocrine therapy: Not specified
- •Radiotherapy: No prior radiotherapy
- •No prior debulking surgery
- •No prior chest tube drainage with sclerosis if tumor resectable
- •Prior thoracentesis allowed
排除标准
- 未提供