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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for malignant pleural mesothelioma (MPM), a cancer affecting the lung lining, using transarterial chemoperfusion. This method delivers three drugs—cisplatin (Platinol), methotrexate, and gemcitabine (Gemzar)—directly to the affected area to assess safety and effectiveness. The trial seeks participants diagnosed with MPM that cannot be surgically removed or have not responded to initial chemotherapy. Participants should have a significant portion of their cancer accessible by this treatment method and should not have received chemotherapy in the last four weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy within 4 weeks before starting the trial, and you cannot be on other investigational drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the combination of cisplatin, methotrexate, and gemcitabine can cause some side effects. Common mild side effects included nausea and anemia, occurring in about 47% of patients. Other side effects, such as low magnesium levels and high potassium levels, were reported in approximately 44% and 41% of patients, respectively.

This treatment has been used in cancer care, with response rates ranging from 12% to 50%. While side effects occur, they are usually manageable. Ongoing research aims to better understand these effects and ensure patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the chemoperfusion treatment for mesothelioma because it delivers chemotherapy drugs directly to the tumor site through the blood vessels, potentially increasing drug concentration at the target while minimizing exposure to the rest of the body. This method uses cisplatin, gemcitabine, and methotrexate, which are already established cancer-fighting agents, but the delivery via transarterial chemoperfusion is unique. Unlike standard treatments that typically involve systemic chemotherapy, this approach may reduce side effects and improve quality of life by focusing treatment where it's needed most.

What evidence suggests that this trial's treatments could be effective for malignant pleural mesothelioma?

Research shows that transarterial chemoperfusion, the treatment participants in this trial will receive, uses the drugs cisplatin, methotrexate, and gemcitabine to treat malignant pleural mesothelioma (MPM), a type of cancer. Studies have found that this treatment can delay disease progression by an average of 2.6 months. Patients have reported few side effects, indicating it is a safe option. Early results suggest that this drug combination can help slow the disease. Overall, the treatment has shown promise in managing symptoms and delaying the progression of MPM. ^{3 5 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02611037

Transarterial Chemoperfusion: Cisplatin, Methotrexate, ... The purpose of this study is to determine whether the transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine is safe and effective ...

2. jvir.org jvir.org/article/S1051-0443(22)01618-9/fulltext

A Phase 2 Prospective Study Transarterial chemoperfusion treatment with cisplatin, methotrexate and gemcitabine in every 4 weeks is feasible and safe. The treatment has promising ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2016-00002

Transarterial Chemoperfusion: Cisplatin, Methotrexate, ... Transarterial chemoperfusion with cisplatin, methotrexate, and gemcitabine hydrochloride may be an effective treatment for malignant pleural mesothelioma.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23151824/

a palliative treatment for malignant pleural mesothelioma Mean time to disease progression was 2.6 months for all tumors, 1.5 months for stable disease, and 1.3 months for progressive disease.

5. evtoday.com evtoday.com/news/transarterial-chemoperfusion-studied-for-treating-mesothelioma

Transarterial Chemoperfusion Studied for Treating ... Transarterial chemoperfusion treatment for malignant pleural mesothelioma (MPM) results in minimal side effects and shows promise for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6204415/

Current chemotherapy strategies in malignant pleural ... Response rates for these combinations have ranged from 12% to 50%, with acceptable levels of toxicity. However, it is generally accepted that mesothelioma ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1556086415304883

Recent Advances in the Treatment of Malignant Pleural ... 37, 43 When administered at 60 mg/m2 iv every 3 weeks, responses have been demonstrated in 10 to 15% of patients, with a median survival of 8 to 10 months.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2782121/

Systemic Treatments for Mesothelioma: Standard and Novel The combination of vinorelbine with cisplatin yielded a response rate of 29.6% and a median survival of 16.8 months [35]. The phase III MS01 trial, from the ...