Study on Liothyronine and BIT Regimen for Treating Medulloblastoma in Children and Young Adults
Sponsor: Sabine Mueller, MD, PhD
ClinicalTrials ID:NCT07346157
This clinical trial is testing a new treatment combining liothyronine (L-T3) with standard chemotherapy drugs for children and young adults with medulloblastoma, a type of brain cancer, that has returned or progressed after initial treatment.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of combining liothyronine (L-T3) with chemotherapy drugs bevacizumab, irinotecan, and temozolomide (BIT) in treating medulloblastoma in children and young adults. It includes two phases: Phase 1 focuses on dose escalation to find the right dose, and Phase 2 tests the treatment's ability to clear cancer markers in the cerebrospinal fluid (CSF). Participants can continue treatment for up to 12 cycles if they tolerate it well and show no disease progression.
Description
This study is divided into two parts: Phase 1 and Phase 2.
In Phase 1, researchers will test increasing doses of liothyronine (L-T3) combined with chemotherapy drugs bevacizumab, irinotecan, and temozolomide (BIT) to find the safest and most effective dose for children and young adults with medulloblastoma that has returned or progressed after initial treatment.
In Phase 2, the focus is on patients with medulloblastoma who have cancer markers in their cerebrospinal fluid (CSF) but no visible tumor growth. This phase will test if liothyronine (L-T3) alone can clear these cancer markers.
Participants may continue treatment for up to 12 cycles if they do not experience severe side effects or disease progression. Those benefiting from the treatment may continue liothyronine (L-T3) alone for an additional year. Follow-up will continue until the participant withdraws or passes away.
The study aims to complete enrollment within five years, including three years for enrolling participants and two years for follow-up.
Eligibility Criteria
Inclusion Criteria
- Children and young adults aged 1-25 years with medulloblastoma that has returned or progressed after initial treatment.
- Must have received standard initial treatment, including radiation or high-dose chemotherapy.
- For Phase 1: Must have measurable or evaluable disease.
- For Phase 2: Must have cancer markers in the cerebrospinal fluid (CSF) but no visible tumor growth.
- Must have good organ function and meet specific blood count and health criteria.
- Must not have had major surgery recently and must be stable on any thyroid medication.
- Must agree to use effective birth control during and after the study if of childbearing potential.
- Must be able to understand and sign consent forms.
Exclusion Criteria
- Previous treatment with the BIT regimen.
- Recent chemotherapy or radiation that affects blood counts.
- Use of other investigational drugs or treatments.
- Allergies to study drugs or similar compounds.
- Uncontrolled illnesses or infections.
- Pregnant or breastfeeding women.
- Unstable HIV treatment or severe immune system issues.
- Severe malnutrition or heart problems.
- Uncontrolled high blood pressure or diabetes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Francisco | 94143 | San Francisco | California |
| Children's National Hospital | 20010 | Washington D.C. | District of Columbia |
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