Actively Recruiting
A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in Children With Relapsed or Refractory Solid Tumors
Led by M.D. Anderson Cancer Center · Updated on 2025-11-10
48
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To find the recommended dose of eribulin that can be given in combination with irinotecan and temozolomide to treat relapsed and/or refractory solid tumors.
CONDITIONS
Official 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 must be older than 1 year and 25 years or younger at the start of treatment
- Diagnosis of relapsed or refractory solid tumor confirmed by tissue or imaging
- Must have measurable disease
- Patients with treated or stable brain metastases may participate if not needing increased steroids for 7 days
- Karnofsky performance score of 50% or higher for patients over 16 years, Lansky score of 50 or higher for ages 1 to 16
- Prior therapy allowed except prior combination treatment with irinotecan and temozolomide
- Fully recovered from side effects of previous chemotherapy, immunotherapy, or radiation
- Specific waiting periods since last growth factor, radiation, or stem cell transplant as detailed
- Adequate bone marrow function with ANC ≥ 750/μL and platelet count ≥ 75,000/μL without recent transfusion
- Adequate kidney function with creatinine clearance or GFR ≥ 70 ml/min/1.73m2
- Liver function with total bilirubin ≤ 1.5 times upper limit of normal, ALT ≤ 3 times upper limit, and serum albumin ≥ 2 gm/dL
- Informed consent signed by patient or guardian as appropriate
You will not qualify if you...
- Significant organ dysfunction not meeting inclusion criteria
- Patients who are wards of the state or other entity
- Pregnant or breastfeeding individuals
- Use of growth factors supporting platelets or white cells within 7 days before enrollment
- Currently receiving other investigational drugs or anti-cancer agents
- Allergy or intolerance to irinotecan, temozolomide, eribulin, or cephalosporins without alternative antibiotics
- Uncontrolled infection, positive blood cultures within 48 hours, or treatment for Clostridium difficile infection
AI-Screening
AI-Powered Screening
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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
CONTACT
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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