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Title
Status

 

DCL-17-001 - An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children and AYA with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors (CLOVER-2) and Expansion in Children, AYA with Relapsed or Refractory High Grade Glioma

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DCL-17-001 - An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children and AYA with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors (CLOVER-2) and Expansion in Children, AYA with Relapsed or Refractory High Grade Glioma

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DiagnosisGlioblastoma, Astrocytoma, Oligodendroglioma, Mixed Glioma, Pleomorphic Xanthoastrocytoma, Ganglioglioma, DIPG, Ependymoma Study StatusOpen
PhaseI/II
AgeChild, Adult - (10 years to 25 years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationCLR 131 administered intravenously, fractionated dose Arm 1: two planned cycles, 20 mCi/m2 on day 1 and day 15 Arm 2: three planned cycles, 10mCi/m2 on day 1 and day 15
Last Posted Update2023-11-10
ClinicalTrials.gov #NCT03478462
International Sponsor
Cellectar Biosciences, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects of a medication called CLR131. This medication is a targeted radiopharmaceutical, which means it acts like radiation therapy, but is given intravenously as an infusion. 

CLR 131 is designed to target cells with cancer rather than cells without cancer. The main goal of this study is to determine what is the safe amount of medication to give to children with cancer that has come back or is not responding to treatment.

 

Inclusion Criteria
  • Age between 10 and 25 years
  • High Grade Glioma that has come back (relapse) or not improved despite treatment (progression)
  • Must meet all bloodwork requirements
  • Patient must be up and about at least 60% of their waking hours
  • Patient must be willing to comply with study visit requirements and sign a consent form 

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team