New drug cocktail aims to tackle childhood cancers that Won't quit
NCT ID NCT06006273
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether adding a drug called eribulin to two standard chemotherapy drugs (irinotecan and temozolomide) is safe for children and young adults up to age 25 with solid tumors that have returned or not responded to treatment. The main goal is to find the best dose of eribulin for this combination. About 48 participants will be enrolled, and researchers will closely monitor side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eribulin, irinotecan, and temozolomide
- What this could lead to
- If successful, this could point toward a new treatment option for children with hard-to-treat solid tumors that have come back or not responded to standard therapy.
- What could go wrong
- This is an early phase 1 trial with only 48 participants, focused on safety and dosing—not yet on effectiveness. The combination may cause significant side effects and may not shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. 1. Hematopoietic growth factor: At least 7 days must have elapsed since the last administration of filgrastim, or 14 days since administration of pegfilgrastim. 2. XRT: At least 7 days since the last dose of local palliative radiation therapy. Greater than 6 months must have elapsed since the last day of treatment if given total body irradiation, craniospinal irradiation. 3. Autologous or Allogenic Stem Cell Transplant: Complete resolution of graft versus host disease and no current need for immunosuppressive medication. Greater than 3 months must have elapsed since engraftment and no longer requiring transfusion of platelets or injection of colony stimulating factors. * Organ Function Requirements * Bone Marrow Function: 1. Peripheral absolute neutrophil count (ANC) ≥ 750/µL 2. Platelet count ≥ 75,000/µL (no platelet transfusion within 7 days prior to obtaining laboratory result) * Adequate Renal Function: a. Creatinine clearance or glomerular filtration rate ≥ 70ml/min/1.73m2 (calculated or measured as appropriate for age and level of concern by treating MD) * Adequate Liver Function: 1. Total bilirubin ≤ 1.5x upper limit of normal (ULN) for age 2. SGPT (ALT) ≤ 3 x ULN 3. Serum albumin ≥ 2gm/dL Due to the risk of hepatic injury, including fatal hepatic failure, temozolomide should not be administered if total bilirubin is \>2.0 mg/dl or SGPT(ALT)\> 3 x ULN. Informed Consent: All patients ≥ 18 years of age must sign a written informed consent. For patients \< 18 years old, the patient's parents or legal guardians must sign a written informed consent, unless the patient is an emancipated minor. Childhood Assent, when age appropriate as per institutional guidelines, should be signed by the participating patient. Consent may be obtained virtually, as per institutional guidelines. Exclusion Criteria: * Significant organ dysfunction, not meeting inclusion criteria. * 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: 1. Allergy or intolerance to agents on this protocol: irinotecan, temozolomide, or eribuin 2. Allergy to cephalosporins, without a reasonably available antibiotic alternative * Infection: Patients who have uncontrolled infection, positive blood cultures within the past 48 hours, or receiving treatment for Clostridium difficile infection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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