LAM561 for Pediatric Brain Tumor
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you need warfarin, phenytoin, or certain diabetes medications. It's best to discuss your current medications with the trial team.
What evidence supports the effectiveness of the drug LAM561 for treating pediatric brain tumors?
Research shows that 2-hydroxyoleic acid, a component of LAM561, has anti-cancer activity and can selectively kill glioma cancer cells, a type of brain tumor, without harming normal cells. It has been tested in a clinical trial for safety and preliminary effectiveness in patients with glioma, showing potential as a treatment.12345
What makes the drug LAM561 unique for treating pediatric brain tumors?
What is the purpose of this trial?
This trial tests a new drug called LAM561 in children with severe brain and other solid tumors. The goal is to find the safest and most effective dose by adjusting it and monitoring side effects. If the drug shows benefits without severe side effects, patients can continue using it even after the trial ends.
Eligibility Criteria
This trial is for children under 18 with advanced high-grade gliomas or other solid tumors that are getting worse, coming back, or not responding to standard treatments. They must be able to take oral medication and have good enough blood counts and organ function. Kids who can't walk due to paralysis but use a wheelchair can join too.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive LAM561 in a dose escalation phase to establish dose-limiting toxicity and a safe dose
Expanded Safety Cohort
Participants are treated at the Maximum Tolerated Dose to assess safety and determine the Recommended Phase 2 Dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Compassionate Use Extension
Participants demonstrating clinical benefit may continue treatment under compassionate use
Treatment Details
Interventions
- 2-OHOA
- LAM561
2-OHOA is already approved in European Union, United States for the following indications:
- None approved yet; Orphan designation for glioma
- None approved yet; Orphan designation for glioma and Fast-Track designation for glioblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laminar Pharmaceuticals
Lead Sponsor
Dana-Farber Cancer Institute
Collaborator
Laminar Pharma Inc
Collaborator
Hackensack Meridian Health
Collaborator