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

April 16, 2013 updated by: Fox Chase Cancer Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Office of S. Terry Kraus
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Corey J. Langer, MD, Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1996

Primary Completion (Actual)

December 1, 1999

Study Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 10, 2004

First Posted (Estimate)

September 13, 2004

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066157
  • P30CA006927 (U.S. NIH Grant/Contract)
  • FCCC-96087
  • NCI-G98-1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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