Back to search results

Phase Ib Eribulin, Irinotecan, and Temozolomide for Relapsed/Refractory Solid Tumors

This study is a Phase Ib clinical trial for children and young adults (ages 1 to 25) with solid tumors that have returned or not responded to previous treatments. It is testing a combination of three drugs: Eribulin (given by IV, into a vein), Irinotecan (given by IV), and Temozolomide (given by mouth). The main goal is to find the safest and most effective dose of Eribulin when given with Irinotecan and Temozolomide. Researchers will also be looking at how safe this drug combination is and if it helps shrink tumors or slow their growth. The study plans to enroll 48 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 48 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events (side effects) through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06006273

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

Recruiting
PHASE1Ages 1–25InterventionalTreatment
M.D. Anderson Cancer Center
~48 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:EribulinIrinotecanTemozolomide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 1 year

Conditions

Refractory Solid Tumors

Explore related trials

Solid Neoplasm

NCT06006273

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Fiorela Hernandez Tejada, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Fiorela Hernandez Tejada, MD
[email protected]
(832) 306-9802
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age: Patients must be \> 1 year of age and ≤ 25 years of age at time of initiation of protocol therapy.
Diagnosis: Patients have a histologically or radiographically confirmed relapsed or refractory solid tumor.
Disease Status: Patients must have evaluable disease.
Patients may have CNS metastases at study entry, if they are previously treated or stable (defined by not requiring initation or increased steroids for 7 days).
Performance Level: Karnofsky ≥ 50% for patients \>16 years old, and Lansky ≥ 50 for patients 1-16 years old. (Appendix I)
Prior Therapy: Patients may have received prior therapy including single-agent irinotecan or temozolomide. Patients may not have previously been treated with combination therapy of irinotecan and temozolomide.
Patients must be fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Organ Function Requirements
Bone Marrow Function:
Adequate Renal Function:
Adequate Liver Function:
Pediatric subjects who are considered wards of some entity
Pregnancy or Breast-Feeding
Pregnant or breast-feeding woman will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies.
Concomitant Medications:
Growth factor: Growth factors that support platelet or white cell number of function must not have been administered within the past 7 days.
Investigational Drugs: Patients who are currently receiving another investigational drug. (Please refer to Prior Therapy, section 2.1.5)
Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents. (Please refer to Prior Therapy, section 2.1.5.1)
Medication Allergy:
Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.

What this trial measures

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year