Cisplatin, Interferon Alfa, Surgery, and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 2000-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Interferon-alpha; Interferons

Criteria

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

• Hepatic:

• Bilirubin less than 2.0 mg/dL

• No autoimmune hepatitis

• No history of decompensated liver disease; e.g. esophageal varices

• Ascites

• 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

• Other:

• 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

• Surgery:

• No prior debulking surgery

• No prior chest tube drainage with sclerosis if tumor resectable

• Prior thoracentesis allowed