← Back to Search

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 below

Select...

My heart and blood vessels are healthy, with no major diseases or uncontrolled high blood pressure.

Select...

My liver tests are within normal limits.

Select...

My cancer can be measured or seen on tests.

Select...

My cancer has not spread to my brain.

Select...

My cancer is confirmed as mesothelioma in the lining of my chest or abdomen.

Select...

My kidney function, measured by creatinine, is normal.

Select...

I am fully active or can carry out light work.

Select...

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

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

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

0 / 8Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different hospitals are conducting this research study?

"There are 7 sites currently running this trial, with more spread out locations like South Bend, Baltimore and Albuquerque. If you enroll in the trial, it is beneficial to try and be assigned a site that is closer to your home to avoid extensive travel."

Answered by AI

Are we still looking for people to participate in this trial?

"According to the latest information on clinicaltrials.gov, this particular trial is not looking for any more patients at this time. The study was initially posted on 5/1/1997 and was most recently edited on 11/5/2013. However, there are still 539 other studies that are actively recruiting patients right now."

Answered by AI

What is ranpirnase used to treat most often?

"ranpirnase is most often used to treat lymphoma and hodgkins, but it has also been taken to help manage other conditions like bronchogenic carcinoma, neuroblastoma, and sezary syndrome."

Answered by AI

Has the FDA greenlit ranpirnase for therapeutic use?

"There is some clinical data to support the efficacy of ranpirnase and it has received multiple rounds of safety testing, so our team at Power gave it a score of 3."

Answered by AI

Is ranpirnase a common medication in other research?

"The first clinical trial involving ranpirnase was conducted in 1997 at Spectrum Health Hospital - Butterworth Campus. In the years since, there have been a total of 679 completed trials. At present, 381 different studies are active with a large concentration based out of South Bend, Indiana."

Answered by AI

How many people are being asked to participate in this clinical trial?

"Unfortunately, this specific clinical trial is not presently looking for new participants. Although, it is worth noting that there are 158 trials actively enrolling patients with mesothelioma and 381 trials for ranpirnase that are admitting new participants as we speak."

Answered by AI

Is this a groundbreaking clinical trial?

"Since 1997, ranpirnase has undergone a variety of clinical trials. The first was sponsored by Alfacell and took place in1997 with 300 participants. After this initial study, ranpirnase received approval to enter Phase 3 drug trials. As of now, there are 381 activeranpirnase trials being conducted across 67 different countries and 1935 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

1997. "ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003034.

All > Mesothelioma > Ic