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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

Phase 1
18 Years
Not Enrolling
Malignant Mesothelioma

Thank you

Trial Information

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

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.

Inclusion Criteria


- Histologically proven ipsilateral malignant pleural mesothelioma

- No contralateral thoracic or intra-abdominal involvement

- No distant metastases


- 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

- No psychosis

- No uncontrolled thyroid abnormalities

- No active infection requiring intravenous antibiotics


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1996

Completion Date:

November 2000

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • Mesothelioma



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