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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 histologically or cytologically proven advanced solid tumors for which standard treatments are not available, or for whom the current dose level of cisplatin in combination with pemetrexed is appropriate; =< 2 prior cytotoxic chemotherapy regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 advanced cancer has no standard treatment left, or I can receive cisplatin with pemetrexed.
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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 a solid tumor or mesothelioma that can be measured by specific criteria, excluding fluid buildup.
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I am using or willing to use birth control during and up to 4 months after the study.
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I have an advanced tumor that hasn't been treated with chemotherapy and can't be surgically removed.
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My kidney function is within the required range for my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-methoxyamine and cisplatin, and at 15 and 30 minutes, 1, 2, 4, 6, and 24 hours post cisplatin on course 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-methoxyamine and cisplatin, and at 15 and 30 minutes, 1, 2, 4, 6, and 24 hours post cisplatin on course 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity (Arm A)
Response rate (Arm B)
Secondary outcome measures
Establishment of pleural and peritoneal effluent-derived cell lines
Objective clinical response
Pharmacokinetic (PK) parameter
+1 more

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
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed Disodium
2015
Completed Phase 2
~280
Methoxyamine
2007
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,616 Total Patients Enrolled
Marianna KoczywasPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
2 Previous Clinical Trials
61 Total Patients Enrolled

Frequently Asked Questions

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

How many patients are involved in this clinical research project?

"This study is no longer recruiting participants. The trial was initially posted on August 11th, 2015 and updated for the final time on November 15th, 2022. There are 4951 trials currently enrolling patients with recurrent peritoneal malignant mesothelioma and 865 studies involving Methoxyamine that are actively looking for participants."

Answered by AI

Can people with the required medical conditions participate in this trial at this time?

"Unfortunately, this study is not recruiting patients at the moment. The listing was published on August 11th, 2015 and last edited November 15th, 2022. However, there are 4951 other trials for recurrent peritoneal malignant mesothelioma and 865 for Methoxyamine that are still enrolling patients if you're interested."

Answered by AI

How has Methoxyamine been traditionally employed?

"Methoxyamine has shown to be an effective treatment against malignant neoplasms, ovarian cancer, and unresectable thymoma."

Answered by AI

Is this clinical trial also being conducted in any other locations besides Canada?

"Currently, this clinical trial has 15 sites open for enrollment. These locations are situated in Columbus, Nashville and Madison with other cities making up the remaining 12 locations. If you are selected to participate, it would be most convenient for you if the site was close to your location to reduce travel requirements."

Answered by AI

What goals does this research hope to achieve?

"The purpose of this 8-week study is to establish a maximum tolerated dose (in Arm A). Additionally, the trial will monitor for objective clinical responses (defined as RECIST-defined responses summarized as a fraction of all subjects), and feasibility of establishing pleural and peritoneal effluent-derived cell lines. Lastly, cultured mesothelioma cells' response to cisplatin, pemetrexed, and methoxyamine in patients will be compared."

Answered by AI

What similar studies has Methoxyamine been a part of in the past?

"Methoxyamine was first researched in 1997 by the City of Hope Comprehensive Cancer Center. There have been 1160 studies completed with 865 currently active clinical trials, many of which are based in Columbus, Ohio."

Answered by AI
~3 spots leftby Mar 2025