The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.
Even with standard, highly toxic multimodality therapies and salvage regimen, most pediatric patients with primary metastatic or relapsed solid tumors are confronted with a poor prognosis. For these patients there is currently no accepted successful treatment regimen. There is a need for new drugs, including targeted radiopharmaceuticals, preferably with cancer-specific uptake and broad applicability for these rare pediatric malignancies. CLR 131 is a radioiodinated therapeutic that exploits the selective uptake and retention of phospholipid ethers (PLEs) by malignant cells. Cellectar Biosciences' novel cancer-targeted small-molecule compound (CLR1404) is radiolabeled with the isotope iodine-131 (I-131). CLR 131 has demonstrated tumor selective uptake across numerous adult and pediatric cancer cell types. Therapeutic efficacy has been demonstrated in various pediatric and adult-type cancer xenograft models, confirming the ability of CLR 131 to target tumors. Based on the critical unmet medical need for effective agents with novel mechanisms of action in relapsed pediatric cancers and initial preclinical and clinical experience with radioiodinated CLR1404, Cellectar Biosciences has chosen to assess CLR 131 in a phase 1 pediatric trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
IV dose of CLR 131, increased/decreased by dose level; single or fractionated dose
Lucile Packard Children's Hospital
Palo Alto, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children's Hospital
Houston, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Hospital for Sick Children
Toronto, Ontario, Canada
Number of participants with dose limiting toxicities (DLT)
DLT will be assessed by physical examination, vital signs, and laboratory values
Time frame: up to 64 days
Identification of recommended phase 2 dose of CLR 131 in children, adolescents, and young adults
Dose and regimen to be used in Phase 2 trials of CLR 131 in children, adolescents, and young adults
Time frame: until non-tolerated dose is defined; dose escalation decision made upon review of data from a complete cohort (85 days after all subjects in cohort have received infusion)
Determination of preliminary antitumor activity of CLR 131 in children, adolescents, and young adults
Response assessment per applicable criteria (e.g., Neuroblastoma Response Criteria (modified); RECIST 1.1; positron emission tomography response criteria in solid tumors (PERCIST); RANO)
Time frame: through Day 85
Determination of therapeutic activity of CLR 131 in children, adolescents, and young adults
Assessment via 131-I/CLR 131 SPECT/CT scans
Time frame: up to 22 days post initial infusion
Determination of event free survival following CLR 131 infusion in children, adolescents, and young adults
Time from first infusion of CLR 131 until progression or recurrence of disease
Time frame: 1 month to 5 years
Determination of overall survival following CLR 131 infusion in children, adolescents, and young adults
Time from first infusion of CLR 131 until death due to any reason
Time frame: 1 month to 5 years
Determine dosimetry of CLR 131 in children, adolescents, and young adults
Assessment of dosimetry via whole body planar imaging
Time frame: up to 15 days post initial infusion
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