Actively Recruiting
A Phase Ib Trial of Eribulin Combined With Irinotecan and Temozolomide in Children With Relapsed or Refractory Solid Tumors
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best dose of eribulin when given together with irinotecan and temozolomide to treat children and young adults aged 1 to 25 years who have relapsed or refractory solid tumors. This phase Ib trial aims to find the maximum tolerated dose and recommended phase 2 dose of eribulin combined with fixed doses of irinotecan and temozolomide. The study also monitors safety, tolerance, and disease response including tumor activity and progression-free survival. Participants will receive treatment in one of several groups based on their tumor type, including Ewing sarcoma, rhabdomyosarcoma, other solid tumors, or dose finding levels. Eribulin and irinotecan are given by vein (IV), while temozolomide is taken by mouth. The first phase involves dose escalation to determine the recommended dose combination, after which patients receive treatment at that dose in the expansion phase. During the study, participants will be closely monitored for side effects using standardized criteria and evaluated for tumor response and symptom relief. Assessments include physical exams, laboratory tests, and imaging to track disease status. The study will continue through completion with an average follow-up of about one year to observe safety and treatment outcomes in this population.
CONDITIONS
Brief Title
A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged greater than 1 year and less than or equal to 25 years at the start of treatment
- Histologically or radiographically confirmed relapsed or refractory solid tumor
- Patients must have evaluable disease
- Patients with previously treated or stable CNS metastases may be included
- Performance level of at least 50% on Karnofsky scale for those over 16 years or Lansky scale for those 1 to 16 years old
- Prior therapy allowed except prior combination of irinotecan and temozolomide
- Full recovery from acute toxic effects of prior therapies including chemotherapy, immunotherapy, or radiotherapy
- Specific recovery times after growth factor use, radiation therapy, and stem cell transplant as detailed
- Adequate bone marrow, renal, and liver function as defined by laboratory thresholds
- Written informed consent obtained from patients or guardians as appropriate
You will not qualify if you...
- Significant organ dysfunction not meeting inclusion criteria
- Pediatric subjects considered wards of some entity
- Pregnancy or breastfeeding
- Use of growth factors supporting platelets or white cells within 7 days
- Current use of other investigational drugs or anti-cancer agents
- Allergy or intolerance to irinotecan, temozolomide, eribulin, or cephalosporins without alternatives
- Uncontrolled infection, recent positive blood cultures, or treatment for Clostridium difficile infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive eribulin in combination with irinotecan and temozolomide to treat relapsed or refractory solid tumors. The treatment dose may vary depending on the dose finding phase and participant's disease type.
Weekly visits during each treatment cycle
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Fiorela Hernandez Tejada, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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