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Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive ranpirnase 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 ranpirnase as a single agent until disease progression.

Drug: doxorubicin hydrochlorideDrug: ranpirnase

Arm II

EXPERIMENTAL

Patients receive doxorubicin as in arm I for up to 6 courses.

Drug: doxorubicin hydrochloride

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed malignant pleural or peritoneal mesothelioma * Measurable or evaluable disease * CALGB groups 1-4 * No CNS metastases PATIENT CHARACTERISTICS: Age: * 21 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 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 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

Study Sites (19)

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

CCOP - Duluth

Duluth, Minnesota, 55805-1983, United States

Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles

Saint Charles, Missouri, 63301, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114-4199, United States

University of New Mexico Cancer Research and Treatment Center

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Doxorubicinranpirnase

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural Neoplasms

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1997

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Arm I

Arm II

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (19)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Arm I

Arm II

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (19)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations