Clinical Trial · NCT03478462

Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas

Overview

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.

Sponsor

Cellectar Biosciences

Phase

Phase 1

Contacts

Jarrod Longcor (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03478462

Drug / Compound

CLR1404

Isotope(s):

Target(s):

Phospholipid Metabolism

Ligand Class: Small Molecules

Eligibility

Inclusion

At least 1 measurable lesion with longest diameter of at least 10 mm on any imaging sequence.
Patients who have undergone autologous or allogeneic bone marrow transplant must be at least 3 months from transplant.
Platelets ≥ 75,000/µL (last transfusion, if any, must be at least 1 week prior to study registration, and, unless deemed medically necessary, no transfusions are allowed between registration and dosing)
Using the bedside Schwartz formula, estimated GFR (creatinine clearance) \> 60 ml/min/1.73m2
Patients with previously known neurological deficits must be clinically stable at time of enrollment and able to complete all study related procedures. Patients with documented or newly diagnosed neurological deficits will be enrolled at the investigator's discretion.

Exclusion

For solid tumor and lymphoma patients only, central nervous system involvement unless previously treated with surgery, systemic therapy, or radiotherapy with the patient neurologically stable. Patients with metastatic brain tumors that have been previously treated are allowed, provided the patient is neurologically stable (determined at the investigator's discretion).
Patients previously treated with iodine-131 (131I)-MIBG who have already received a cumulative I-131 dose \> 54 mCi/kg or who would exceed 54 mCi/kg by participating in this trial, are not eligible.
Patients receiving active treatment for central nervous system metastases or those that are likely to require active treatment during anticipated participation in this trial. Patients with stable brain metastases treated with steroids may enroll at the investigator's discretion