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Mesothelioma Related Clinical Trials:
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
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Active
Sponsors and Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00003263
Condition: Malignant Mesothelioma
Intervention: Drug: cisplatin; Drug: recombinant interferon alfa; Procedure: chemotherapy; Procedure: interferon therapy; Procedure: radiation therapy; Procedure: surgical procedure
Purpose:
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.
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | August 1996 |
Detailed Description:
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.
Eligibility:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS: Histologically proven ipsilateral malignant pleural mesothelioma No contralateral thoracic or intraabdominal 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 posttreatment 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
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003263Locations
| United States, Louisiana | |||||
| Office of S. Terry Kraus | |||||
| Marrero, Louisiana, United States, 70072 | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| United States, Virginia | |||||
| Virginia Oncology Associates | |||||
| Newport News, Virginia, United States, 23606 | |||||
Sponsors and Collaborators
| Fox Chase Cancer Center |
| National Cancer Institute (NCI) |
Investigators
| Study Chair: | Corey J. Langer, MD | Fox Chase Cancer Center |
Additional Information:
| Study ID Numbers: | CDR0000066157, FCCC-96087, NCI-G98-1401 |
| First Received: | November 1, 1999 |
| Last Updated: | October 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00003263 |
| Health Authority: | United States: Federal Government |
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