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 | Unknown Phase 3

• 3 other identifiers: CDR0000065639ALFACELL-P30-302NCI-V97-1273
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 19

Brief 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

Keywords

localized malignant mesothelioma; advanced malignant mesothelioma; recurrent malignant mesothelioma

Outcome Measures

Primary Outcomes (1)

• Survival

Secondary Outcomes (3)

• Objective response

• Time to best response

• Response duration

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 hydrochloride; Drug: ranpirnase

Arm II

EXPERIMENTAL

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

Drug: doxorubicin hydrochloride

Interventions

doxorubicin hydrochloride DRUG

Given IV

Arm I; Arm II

ranpirnase DRUG

Given IV

Arm I

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alfacell: lead

Study Sites (19)

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805-1983, United States

Location

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

Saint Charles, Missouri, 63301, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114-4199, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Asklepios Fachkliniken Muenchen-Gauting

Gauting, D-82131, Germany

Location

Hospital Grosshansdorf

Großhansdorf, D-22927, Germany

Location

Asklepios Klinik St. Georg

Hamburg, D-20099, Germany

Location

Asklepios Klinik Harburg

Hamburg, D-21075, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Ospedale San Martino

Genoa, 16132, Italy

Location

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

University School of Medical Sciences

Poznan, PL-60 569, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Klinika Chrorob Pluc I Gruzlicy

Zabrze, 41-803, Poland

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Doxorubicin; ranpirnase

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Diane Scudiery

  Alfacell

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 1, 1997
• Primary Completion: February 1, 2008
• Last Updated: November 6, 2013

Record last verified: 2007-10

Locations

DE (5); US (7); PL (4); IT (3)