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Brief Title: Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG
Official Title: A Phase 1b, Open-Label, Study of a Novel Targeted Radiotherapy in Children, Adolescents and Young Adults With Inoperable Relapsed or Refractory High-Grade Glioma
Study ID: NCT05610891
Brief Summary: 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).
Detailed Description: This study is designed to further evaluate the safety and tolerability of CLR 131 at the selected doses in children, adolescents and young adults with relapsed or refractory malignant high-grade glioma. It will also determine the therapeutic activity defined as progression free survival and overall survival, antitumor activity (treatment response) defined as the reduction in tumor volume and identify the recommended Phase 2/3 dose of CLR 131 in children, adolescents and young adults with relapsed or refractory HGG.
Minimum Age: 10 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Palo Alto, California, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Texas Children's Cancer Center, Baylor College of Medicine, Houston, Texas, United States
University of Wisconsin, Carbone Cancer Center, Madison, Wisconsin, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Name: Jarrod Longcor
Affiliation: Chief Operating Officer
Role: STUDY_DIRECTOR