Phase Ib Study of Eribulin with Irinotecan and Temozolomide for Children with Hard-to-Treat Solid Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06006273

Provider View

This clinical trial is testing a combination of three drugs—eribulin, irinotecan, and temozolomide—to find the best dose and see if it can help treat children with solid tumors that have returned or are not responding to treatment.

Patient Parameters

Program Overview

The aim of this study is to determine the safest and most effective dose of eribulin when used with irinotecan and temozolomide in children with solid tumors that have come back or are not responding to treatment. Researchers will also monitor how well the tumors respond to this combination of drugs and if it helps relieve symptoms.

Description

This study is focused on finding the right dose of eribulin when combined with irinotecan and temozolomide for children with solid tumors that are difficult to treat. The primary goal is to identify the maximum dose that can be safely given without causing severe side effects. Researchers will also observe how the tumors respond to this treatment and if it provides any symptom relief.

The study will monitor the overall response of the tumors, including how long the response lasts and the time patients remain free from disease progression. Although the benefits of this drug combination are not yet established, the study aims to offer a potential treatment option for these patients.

Eligibility Criteria

Inclusion Criteria

  • Age: Children and young adults aged 1 to 25 years.
  • Diagnosis: Must have a confirmed solid tumor that has returned or is not responding to treatment.
  • Disease Status: Must have a tumor that can be measured or evaluated.
  • Can have stable or previously treated brain metastases.
  • Performance Level: Must be able to perform daily activities with some limitations (Karnofsky score ≥ 50% for those over 16, Lansky score ≥ 50 for those 1-16).
  • Prior Therapy: Can have had previous treatments, but not the combination of irinotecan and temozolomide.
  • Must have recovered from any side effects of previous treatments.
  • Organ Function: Must have adequate bone marrow, kidney, and liver function as determined by specific medical tests.
  • Informed Consent: Patients 18 or older must sign consent; for those under 18, a parent or guardian must sign. Assent from the child is required when appropriate.

Exclusion Criteria

  • Significant organ dysfunction not meeting the study's requirements.
  • Children who are wards of the state or another entity.
  • Pregnant or breastfeeding women due to potential risks to the baby.
  • Recent use of growth factors to boost blood cells within the past 7 days.
  • Currently taking other experimental drugs or cancer treatments.
  • Allergies to any of the study drugs or related medications.
  • Uncontrolled infections or recent positive blood cultures.

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