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Cisplatin, Interferon Alfa, Surgery, and Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Fox Chase Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003263
  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.


Condition Intervention Phase
Malignant Mesothelioma
Biological: recombinant interferon alfa
Drug: cisplatin
Procedure: surgical procedure
Radiation: radiation therapy
Phase I

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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: NCT00003263

Locations
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
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066157, FCCC-96087, NCI-G98-1401
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003263     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma

Additional relevant MeSH terms:
Interferon-alpha
Anti-Infective Agents
Interferon Type I, Recombinant
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Mesothelial
Growth Substances
Interferons
Physiological Effects of Drugs
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Cisplatin
Therapeutic Uses
Mesothelioma
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon Alfa-2a
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009