Chemoperfusion for Mesothelioma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Investigational agents, Antiretrovirals

Disqualifiers: Brain metastases, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: Up to 3 years

34 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective in adults with malignant pleural mesothelioma (MPM).

Research Team

Bela Kis, M.D., Ph.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

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.

Inclusion Criteria

I can do most activities by myself without help.

I am a woman who is either not able to have children, past menopause, or willing to use birth control during and after the study.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

I haven't had chemotherapy in the last 4 weeks or I've recovered from its side effects.

I am allergic to certain chemotherapy drugs but not to IV contrast media.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-in Safety Cohort

Initial phase where 3 patients are treated with a reduced dose of methotrexate to evaluate safety

4 weeks

1 visit (in-person)

Treatment

Participants undergo angiogram and transarterial chemoperfusion treatment every 4 weeks with cisplatin, methotrexate, and gemcitabine

Up to 3 years

Every 4 weeks (3-6 weeks interval allowed)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• Cisplatin
• Gemcitabine
• Methotrexate

Trial Overview 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.

Participant Groups

Group I: Chemoperfusion + Questionnaire Experimental Treatment 4 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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+