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Anti-tumor antibiotic

Eribulin + Irinotecan + Temozolomide for Cancer

Phase 1 & 2

Recruiting

Led By Fiorela Hernandez Tejada, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial tests the best dose of a drug to treat cancer that has come back or not responded to treatment.

Who is the study for?

This trial is for children and young adults aged 1 to 25 with relapsed or refractory solid tumors. Participants need proper kidney, liver, and bone marrow function, no severe infections or allergies to cephalosporins, and can't be pregnant. They must have recovered from previous treatments and not received certain drugs recently.Check my eligibility

What is being tested?

The study aims to determine the safe dose of eribulin when combined with irinotecan and temozolomide in treating stubborn solid tumors that haven't responded well to other therapies.See study design

What are the potential side effects?

Eribulin combined with irinotecan and temozolomide may cause side effects like lowered blood cell counts leading to infection risk, fatigue, digestive issues such as nausea or diarrhea, liver problems, allergic reactions, and potential nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D: Dose finding levels 0,-1 and -2Experimental Treatment3 Interventions

The first group of participants in this phase will receive the highest dose of eribulin. Each group of participants enrolled after that will receive a slightly lower dose of the drug. Participants in this phase will be enrolled in 1 of 3 treatment arms, based on their disease type, and will receive the recommended dose combination found in the Dose Escalation phase.

Group II: Arm C: Dose expansion- other solid tumor histologiesExperimental Treatment3 Interventions

Group III: Arm B: Dose expansion -RhabdomyosarcomaExperimental Treatment3 Interventions

Group IV: Arm A: Dose expansion-Ewings sarcomaExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eribulin

2012

Completed Phase 3

~2700

Irinotecan

2017

Completed Phase 4

~2680

Temozolomide

2010

Completed Phase 3

~1930

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,428 Total Patients Enrolled

Fiorela Hernandez Tejada, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

Does this trial have any age restrictions for prospective participants?

"The eligibility critiera for this clinical study encompass those between one year and 25 years of age."

Answered by AI

Who is the ideal participant for this research endeavor?

"To be considered for this trial, prospective patients must have a solid tumor and fall within the age range of 1 year to 25 years. At present, 48 people are being recruited into the research program."

Answered by AI

Are recruitment spots still available for this research endeavor?

"Affirmative. According to records hosted on clinicaltrials.gov, the recruitment for this trial is currently ongoing and began on August 16th 2023; it was recently modified on August 22nd 20203. This study requires 48 individuals from a single medical centre."

Answered by AI

What is the current intake capacity for this medical experiment?

"Affirmative, the information on clinicaltrials.gov implies that this medical experiment is presently recruiting participants. This study was initially listed on August 16th 2023 and has since been revised as of August 22nd 2023. The trial requires 48 patients to be recruited from 1 centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors

2023. "A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006273.