ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
NCT00003034 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2013-11-06
Summary
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: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.
Conditions
- Malignant Mesothelioma
Interventions
- DRUG
-
doxorubicin hydrochloride
Given IV
- DRUG
-
ranpirnase
Given IV
Sponsors & Collaborators
-
Alfacell
lead INDUSTRY
Principal Investigators
-
Diane Scudiery · Alfacell
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1997-05-31
- Primary Completion
- 2008-02-29
Countries
- United States
- Germany
- Italy
- Poland
Study Locations
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