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Alkylating agents

Methoxyamine + Chemotherapy for Mesothelioma

Phase 1 & 2

Waitlist Available

Led By Marianna Koczywas

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients must be able to swallow whole capsules; nasogastric or gastrointestinal (G)-tube administration is not allowed

Patients with malignant pleural or peritoneal mesothelioma who had progressed while being treated with or had recurred within 6 months of being treated with pemetrexed and cisplatin or carboplatin frontline; intervening treatment is allowed

Must not have

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Pregnant women are excluded from this study because TRC102 is agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TRC102, breastfeeding should be discontinued if the mother is treated with TRC102; these potential risks may also apply to other agents used in this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to time of death from any cause, assessed up to at least 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of methoxyamine when given with cisplatin and pemetrexed disodium to see if it can treat patients with solid tumors or mesothelioma that have spread and usually cannot be cured or controlled with standard treatment, or mesothelioma that does not respond to pemetrexed disodium and cisplatin or carboplatin.

Who is the study for?

This trial is for patients with advanced solid tumors or mesothelioma that's spread and can't be cured or controlled with standard treatment, or those whose mesothelioma didn't respond to specific chemotherapy. Participants must have good organ function, limited prior chemotherapy treatments, and a life expectancy over 3 months. They should not be pregnant, breastfeeding, have severe illnesses affecting study compliance, excessive previous cisplatin doses, hemolysis disorders, active brain metastases requiring steroids or antiseizure meds.

What is being tested?

The trial tests methoxyamine combined with cisplatin and pemetrexed disodium to see if it's more effective for treating these cancers than the current standard of care. Methoxyamine might make cancer cells more sensitive to the other drugs. The study will determine the best dose of methoxyamine and evaluate how well this combination works in shrinking tumors.

What are the potential side effects?

Possible side effects include reactions related to drug infusion such as nausea and fatigue; kidney issues due to cisplatin; blood cell count changes leading to increased infection risk; potential liver enzyme elevations; nerve damage causing numbness; hearing loss from high-frequency sounds.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow pills on my own without needing a tube.

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My mesothelioma worsened or came back within 6 months after treatment with pemetrexed and platinum.

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I am fully active or able to carry out light work.

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I have an advanced tumor that hasn't been treated with chemotherapy and can't be surgically removed.

Exclusion Criteria

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

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

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I am not pregnant or breastfeeding.

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I have a blood clot condition and am taking blood thinners.

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I have a condition that causes my red blood cells to break down.

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I am allergic to medications similar to TRC102, pemetrexed, or cisplatin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to time of death from any cause, assessed up to at least 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to time of death from any cause, assessed up to at least 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of death from any cause, assessed up to at least 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD)

Number of Participants With at Least One Dose Limiting Toxicity (DLT) - Phase I

Number of Subject With Overall Response

Secondary study objectives

Overall Survival

Progression-free Survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (methoxyamine, pemetrexed disodium)Experimental Treatment2 Interventions

Patients receive methoxyamine PO QD on days 1-4 and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue methoxyamine and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.

Group II: Arm A (methoxyamine, pemetrexed disodium, cisplatin)Experimental Treatment3 Interventions

Patients receive methoxyamine PO QD on days 1-4, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue methoxyamine and pemetrexed disodium beyond cycle 6 if the patient continues to benefit from treatment at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pemetrexed Disodium

2015

Completed Phase 2

~450

Cisplatin

2013

Completed Phase 3

~3120