What side effects are associated with this type of intervention?

The most common treatments for Mesothelioma, particularly taxanes like Milataxel, often result in side effects such as myelosuppression, which includes neutropenia (a low count of neutrophils, a type of white blood cell), increasing the risk of infection. Other side effects include neuropathy (nerve damage causing pain or numbness), hypersensitivity reactions, nausea, vomiting, and fatigue. These treatments can also cause alopecia (hair loss) and gastrointestinal issues. The severity and occurrence of these side effects can vary based on the specific drug and patient condition.

What prior FDA approvals exist?

The FDA has approved several treatments for malignant pleural mesothelioma, though specific taxanes like Milataxel are not commonly listed among them. Approved treatments often include pemetrexed in combination with cisplatin, which has been a standard first-line therapy. Other agents like gemcitabine and vinorelbine have been used in second-line settings. Investigational therapies and other chemotherapeutic agents have also been explored, but taxanes specifically targeting microtubule stabilization, such as Milataxel, represent a novel approach in this context.

What other types of research exist?

Promising alternatives to Milataxel for Mesothelioma patients include: <ol> <li>Pemetrexed plus gemcitabine: This combination has shown a disease control rate of 50% and a median overall survival of 26.8 months in clinical trials.</li> <li></li> </ol> Bevacizumab: When added to chemotherapy, it has shown to improve progression-free survival and overall survival in Mesothelioma patients. 3. Immunotherapy agents such as pembrolizumab and nivolumab, which have shown efficacy in various cancers and are being explored for Mesothelioma. 4. Novel targeted therapies and combination regimens that are currently under investigation in clinical trials.

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Taxane

Oral Milataxel for Mesothelioma (TL139 Trial)

Phase 2

Waitlist Available

Led By Harvey Pass, M.D.

Research Sponsored by Taxolog Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed malignant mesothelioma for which they have received pemetrexed in combination with cisplatin as part of chemotherapeutic regimen.

Recovered from all acute toxicities caused by prior cancer therapies, except for alopecia.

Must not have

Patients who are receiving high dose steroids (more than a dexamethasone-equivalent dose of 4 mg per day).

Patients must not have received any other chemotherapeutic treatment for malignant mesothelioma other than pemetrexed and a platinum agent such as cisplatin.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether a new drug called Milataxel can be used to treat people with Mesothelioma.

Who is the study for?

This trial is for adults with malignant mesothelioma who've had pemetrexed and cisplatin chemotherapy but are now facing disease progression. They should have good organ function, be stable if they have brain metastases, and not suffer from severe neuropathy or conditions affecting drug absorption.

What is being tested?

The study tests Milataxel (TL139), an oral medication potentially better than existing taxanes, to see its effectiveness in treating Mesothelioma patients whose cancer has returned or worsened after initial chemo treatment.

What are the potential side effects?

While specific side effects of Milataxel aren't listed here, common ones for taxane drugs include low blood cell counts leading to infection risk, hair loss, nerve damage causing numbness or pain in hands/feet, muscle aches, and nausea.

Eligibility Criteria

Inclusion Criteria

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

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I have mesothelioma and was treated with pemetrexed and cisplatin.

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I have recovered from side effects of previous cancer treatments, except for hair loss.

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I am expected to live at least 12 weeks and can care for myself.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on high doses of steroids (more than 4 mg of dexamethasone or equivalent).

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I have only been treated with pemetrexed and cisplatin for my mesothelioma.

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I am not pregnant or breastfeeding.

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I have not had major surgery in the last 14 days.

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I have moderate to severe nerve damage in my hands or feet.

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I have a condition that affects how my body absorbs medicine.

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I have brain metastases causing symptoms.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AExperimental Treatment1 Intervention

This is a non-random, multicenter, open label, single agent study. Patients with mailgnanat mesothelioma that has reccured or progressed following chemotherapy, and who qualify for this study, will receive oral milataxel.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Taxanes, including Milataxel, paclitaxel, and docetaxel, are a class of chemotherapy drugs that work by stabilizing microtubules, which are crucial for cell division. By preventing the disassembly of microtubules, these drugs inhibit the ability of cancer cells to divide and proliferate, leading to cell death. This mechanism is significant for Mesothelioma patients as it targets the rapid and uncontrolled cell growth characteristic of the disease, potentially slowing its progression and improving patient outcomes.