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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00003263
First received: November 1, 1999
Last updated: April 16, 2013
Last verified: April 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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 Fox Chase Cancer Center:

Enrollment: 6
Study Start Date: August 1996
Study Completion Date: November 2000
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: recombinant interferon alfa
    vaccine
    Drug: cisplatin Procedure: surgical procedure Radiation: radiation therapy
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Corey Langer, FCCC
ClinicalTrials.gov Identifier: NCT00003263     History of Changes
Other Study ID Numbers: CDR0000066157, P30CA006927, FCCC-96087, NCI-G98-1401
Study First Received: November 1, 1999
Last Updated: April 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
localized malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Interferon-alpha
Interferons
Cisplatin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014