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ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen

 

Basic Trial Information

Phase: Phase III
Type: Treatment
Status: Active
Age: 21 and over
Sponsor: Pharmaceutical / Industry
Protocol IDs: ALFACELL-P30-302, NCT00003034, NCI-V97-1273

Objectives

1. Compare the efficacy of doxorubicin with or without Onconase in patients with malignant pleural or peritoneal mesothelioma.
2. Compare the safety profile of these regimens in these patients.
3. Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed malignant pleural or peritoneal mesothelioma
    • Measurable or evaluable disease
  • CALGB groups 1-4
  • No CNS metastases


Prior/Concurrent Therapy:

Biologic therapy:
  • Not specified
Chemotherapy:
  • No more than one prior systemic chemotherapy regimen
  • No prior doxorubicin
  • At least 6 weeks since prior chemotherapy
Endocrine therapy:
  • Not specified
Radiotherapy
  • Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy
Surgery
  • Prior surgical resection allowed

Patient Characteristics:

Age
  • 21 and over
Performance status
  • ECOG 0-1
Life expectancy
  • Not specified
Hematopoietic
  • WBC greater than 3,500/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
Hepatic
  • SGOT no greater than 2 times upper limit of normal
  • Bilirubin no greater than 2 mg/dL
  • PT and PTT normal
Renal
  • Creatinine normal
Cardiovascular
  • No symptomatic New York Heart Association class II-IV cardiovascular disease
  • No congestive heart failure
  • No angina pectoris
  • No cardiac arrhythmias
  • No uncontrolled hypertension
  • No cerebrovascular disease
Metabolic:
  • No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis
Other:
  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception

  • No serious infection

  • No uncontrolled psychosis or neurologic disease (e.g., seizure disorders)

  • No uncontrolled diabetes mellitus

  • No other primary malignancy within the past 5 years except nonmelanoma skin cancer

  • No senility or emotional instability

Projected Accrual

  • A minimum of 300 patients will be accrued for this study.

Outline

This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to disease histology (epithelioid vs nonepithelioid) and CALGB groups 1-4. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive Onconase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with Onconase as a single agent until disease progression.
  • Arm II: Patients receive doxorubicin as in arm I for up to 6 courses.
Quality of life is assessed.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Alfacell Corporation

Diane Scudiery, Protocol chair
Ph: 973-748-8082

Trial Sites and Contacts

Gauting, Germany
Asklepios Fachkliniken Munchen - Gauting
Joachim Von Pawel, MD
Ph: 49-89-8579-12011

Grosshansdorf, Germany
Hospital Grosshansdorf
Ulrich Gatzemeier, MD
Ph: 49-41-02-601-188
Email: pneumo.onco@t-online.de

Hamburg, Germany

Allgemeines Krankenhaus St. Georg
Axel Hanauske, MD, PhD
Ph: 49-40-2890-2281

Thoraxzentrum Hamburg - Allgemeines Krankenhaus Harburg
Eckhard Kaukel, MD
Ph: 49-40-7921-2241
Email: kaukel@t-online.de

Munich, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Christian Peschel, MD
Ph: 49-89-4140-4111
Email: christian.peschel@lrz.tu-muenchen.de



 
 

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