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Mesothelioma Clinical Trials

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

This study is currently recruiting patients.

Sponsored by

For more information:National Cancer Institute (NCI)

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma.

PURPOSE: Randomizedphase III trial comparing Onconase plus doxorubicin with doxorubicin alone in treating patients with malignant mesothelioma.

Condition Treatment or Intervention
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Drug: doxorubicin
Drug: ranpirnase
Procedure: chemotherapy

This is a Phase III test

  • In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. 

Study Type: Interventional
Study Design: Treatment

Further Study Details: 


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

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.

PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both



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

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