Targeted Radiotherapy for Brain Tumor
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antitumor or investigational therapy, you must wait for a certain period before joining the study. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment CLR 131 for brain tumors?
Research shows that CLR1404, a component of CLR 131, is taken up by brain tumors and retained well, which suggests it could be effective in targeting these tumors. Additionally, in pediatric cancer models, CLR1404 delayed tumor growth and extended survival, indicating its potential as a targeted treatment.12345
Is CLR 131 safe for use in humans?
CLR 131, also known as Iopofosine I-131, has been tested in clinical trials and preclinical studies, showing a favorable safety profile with selective uptake in tumors and minimal side effects in animal models. It has been used in adults and is being considered for pediatric trials, indicating its potential safety across different age groups.25678
What makes the drug CLR 131 unique for treating brain tumors?
CLR 131 is unique because it is a targeted radiotherapy that selectively accumulates in tumor cells, minimizing damage to normal brain tissue. It uses a radioactive isotope, I-131, to deliver radiation directly to the tumor, which can help delay tumor growth and extend survival with fewer side effects compared to traditional radiotherapy.12459
What is the purpose of this trial?
The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).
Research Team
Jarrod Longcor
Principal Investigator
Chief Operating Officer
Eligibility Criteria
This trial is for children, adolescents, and young adults aged 2-25 with high-grade glioma (a type of brain tumor) that has come back or hasn't responded to treatment. They must be in a stable condition, not pregnant, able to follow the study plan, and have certain blood counts and organ functions within specific ranges.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CLR 131 in two dosing cohorts; first arm receives two doses of 20 mCi/m2 each, separated by 14 days for two cycles, with a third optional cycle. Second arm receives two doses of 10 mCi/m2 each, separated by 14 days for three cycles with a fourth optional cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including progression free survival and overall survival assessments.
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- CLR 131
CLR 131 is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma
- Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia
- Diffuse large B-cell lymphoma
- Relapsed or refractory multiple myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cellectar Biosciences, Inc.
Lead Sponsor
National Cancer Institute (NCI)
Collaborator