Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neur… (NCT03478462) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
United States30 participantsStarted 2019-04-30
Plain-language summary
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.
Who can participate
Age range2 Years – 25 Years
SexALL
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Inclusion Criteria:
All Patients
* Previously confirmed (histologically or cytologically) pediatric solid tumor (e.g., neuroblastoma, sarcoma), lymphoma (including Hodgkin's lymphoma), or malignant brain tumors that are clinically or radiographically suspected to be relapsed, refractory, or recurrent for which there are no standard treatment options with curative potential. Note: patients with diffuse intrinsic pontine glioma (DIPG) may enroll without histological or cytological confirmation.
* ≥ 2 years of age and ≤ 25 years of age at time of consent/assent
* If ≥ age 16 years, Karnofsky performance status of ≥ 60. If \< age 16 years, Lansky performance status ≥ 60
* 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)
* Absolute neutrophil count ≥ 750/µL
* Hemoglobin ≥ 8 g/dL (last transfusion 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
* Alanine aminotransferase \< 3 × ULN
* Bilirubin \< 2 × ULN
* Patients who have undergone autologous or allogeneic bone marrow transplant must be at least 3 months from transplant.
* Patients enrolling at total dose levels \> 30 millicurie (mCi)/m2 must have availability or ability to colle…
What they're measuring
1
Number of participants with dose limiting toxicities (DLT)