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Anti-tumor antibiotic

Chemoperfusion for Mesothelioma

Phase 2

Waitlist Available

Led By Bela Kis, M.D., Ph.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%)

The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial will test a new chemo treatment for adults with a specific type of cancer.

Who is the study for?

Adults with malignant pleural mesothelioma (MPM) that's not removable by surgery or those who refuse surgery. They must have tried and not responded to standard chemotherapy, or refused it. Participants need to be in good enough health for the treatment, not pregnant or breastfeeding, willing to use contraception, and able to follow study procedures.Check my eligibility

What is being tested?

The trial is testing a procedure called transarterial chemoperfusion using drugs cisplatin, methotrexate, and gemcitabine. It aims to find out if this method is safe and effective for treating MPM when delivered directly into arteries feeding the tumor.See study design

What are the potential side effects?

Possible side effects include reactions related to cisplatin, methotrexate, and gemcitabine such as nausea, vomiting, kidney problems, mouth sores from methotrexate; low blood counts can also occur increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities by myself without help.

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My main cancer area can be reached for treatment through an artery.

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My mesothelioma cannot be removed by surgery or I choose not to have surgery.

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My cancer, mesothelioma, has been confirmed by lab tests.

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My cancer did not improve after first chemotherapy or I refused it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Disease Control Rate (DCR)

Secondary outcome measures

Occurrence of Treatment Related Toxicity

Overall Survival (OS)

Progression Free Survival (PFS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemoperfusion + QuestionnaireExperimental Treatment4 Interventions

Transarterial Chemoperfusion treatment with cisplatin (35 mg/m^2), methotrexate (100 mg/m^2) and gemcitabine (1000 mg/m^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Methotrexate

2013

Completed Phase 4

~3800

Cisplatin

2013

Completed Phase 3

~1940

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,458 Total Patients Enrolled

1 Trials studying Mesothelioma

13 Patients Enrolled for Mesothelioma

Bela Kis, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Media Library

Mesothelioma Research Study Groups: Chemoperfusion + Questionnaire

Mesothelioma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02611037 — Phase 2

Cisplatin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02611037 — Phase 2

Frequently Asked Questions

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

Does Gemcitabine have a high potential for adverse effects?

"Gemcitabine has some clinical evidence supporting its safety, but not yet efficacy. Therefore, it was given a score of 2."

Answered by AI

Are researchers looking for more people to participate in this trial?

"Unfortunately, this particular clinical trial is not searching for new patients at the moment. It was originally posted on March 4th, 2016 and updated September 27th, 2022. However, there are 1218 other studies involving Gemcitabine and 158 trials concerning mesothelioma that are still recruiting participants."

Answered by AI

What is the main indication for Gemcitabine?

"Gemcitabine is often used to treat patients that have received adjuvant anthracycline-based therapy in the past. Additionally, this medication can be given to those suffering from acute lymphoblastic leukemia (ALL), soft tissue sarcoma (STS), and bladder cancer."

Answered by AI

What previous research has been conducted on Gemcitabine?

"There are 1218 ongoing studies related to Gemcitabine, with a focus on its efficacy in Phase 3 trials. Several of these investigations are based in Shanghai, but 59634 other locations worldwide are also conducting separate trials."

Answered by AI

What is the total subject pool for this clinical investigation?

"This clinical trial is no longer recruiting patients. The study was originally posted on 3/4/2016 and was last edited on 9/27/2022. If you are seeking other studies, there are currently 158 clinical trials actively searching for patients with mesothelioma and 1218 trials for Gemcitabine actively searching for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma

2016. "Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02611037.

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