Suspended

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

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What is being tested

doxorubicin hydrochloride

+ ranpirnase

+ doxorubicin hydrochloride

Drug
Who is being recruted

Adenoma+11

+ Lung Diseases

+ Lung Neoplasms

Over 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 1997
See protocol details

Summary

Principal SponsorAlfacell
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: Compare the efficacy of doxorubicin with or without ranpirnase 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 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. 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.

NCT00003034
Principal SponsorAlfacell
Last updated: November 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenomaLung DiseasesLung NeoplasmsMesotheliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPleural NeoplasmsRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms, MesothelialMesothelioma, Malignant

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group 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.

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

CCOP - Northern Indiana CR Consortium

South Bend, United StatesOpen CCOP - Northern Indiana CR Consortium in Google Maps

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, United States

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, United States

CCOP - Duluth

Duluth, United States
Suspended19 Study Centers