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Anti-tumor antibiotic

ONCONASE + Doxorubicin for Mesothelioma

Phase 3
Waitlist Available
Research Sponsored by Alfacell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Hepatic: SGOT no greater than 2 times upper limit of normal, Bilirubin no greater than 2 mg/dL, PT and PTT normal
Must not have
Radiotherapy: Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial is comparing the effectiveness of doxorubicin alone to doxorubicin plus Onconase in treating patients with malignant mesothelioma.

Who is the study for?
This trial is for adults over 21 with malignant pleural or peritoneal mesothelioma, who've had no more than one chemotherapy regimen and haven't used doxorubicin before. They should have a good performance status, normal kidney function, and no serious heart disease, uncontrolled high blood pressure, strokes, brain metastases or other severe health issues.
What is being tested?
The study is comparing the effectiveness of two treatments: doxorubicin alone versus a combination of Onconase (ranpirnase) plus doxorubicin. It aims to find out which treatment stops tumor cells from growing better in patients with malignant mesothelioma.
What are the potential side effects?
Doxorubicin can cause side effects like hair loss, nausea, vomiting, mouth sores and low blood cell counts leading to increased infection risk. Onconase may add risks such as allergic reactions and potential unknown side effects since it's being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart and blood vessels are healthy, with no major diseases or uncontrolled high blood pressure.
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My liver tests are within normal limits.
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My cancer can be measured or seen on tests.
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My cancer has not spread to my brain.
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My cancer is confirmed as mesothelioma in the lining of my chest or abdomen.
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My kidney function, measured by creatinine, is normal.
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I am fully active or can carry out light work.
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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiotherapy for my disease, but not on my heart.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm IIExperimental Treatment1 Intervention
Patients receive doxorubicin as in arm I for up to 6 courses.
Group II: Arm IExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved

Find a Location

Who is running the clinical trial?

AlfacellLead Sponsor
Diane ScudieryStudy ChairAlfacell

Media Library

Doxorubicin hydrochloride (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00003034 — Phase 3
Mesothelioma Research Study Groups: Arm I, Arm II
Mesothelioma Clinical Trial 2023: Doxorubicin hydrochloride Highlights & Side Effects. Trial Name: NCT00003034 — Phase 3
Doxorubicin hydrochloride (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003034 — Phase 3
~10 spots leftby Dec 2025