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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival
Secondary outcome measures
Objective response
Response duration
Time to best response
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiotherapy for my disease, but not on my heart.My treatment plan does not specify hormone therapy.I've had only one chemotherapy before, not including doxorubicin, and it was over 6 weeks ago.My heart and blood vessels are healthy, with no major diseases or uncontrolled high blood pressure.My liver tests are within normal limits.My cancer can be measured or seen on tests.My cancer has not spread to my brain.I have had surgery to remove a tumor before.My cancer is confirmed as mesothelioma in the lining of my chest or abdomen.My kidney function, measured by creatinine, is normal.My treatment plan for biologic therapy is not decided.I am fully active or can carry out light work.I am 21 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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