Clareo Health | Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Y-mAbs Therapeutics
With
Memorial Sloan Kettering Cancer Center
Age
2–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Consensus of diagnosis must be reached by a multidisciplinary pediatric neuro-oncology team by considering both clinical evidence and MRI presentation. Tissue diagnosis is not required.
The patient must have undergone prior external beam radiotherapy to a dose of 54-60 Gy to the brain stem. At least 4 weeks but no more than 14 weeks must have elapsed from the completion of radiotherapy.
The patient must be in adequate general condition for study, with Lansky or Karnofsky Performance Score of ≥ 50 at study entry .
Lansky Performance scale will be used for patients ≤16 years of age.
The patient must be ≥ 2 and ≤ 21 years old.
Patient must weigh a minimum of 8 kg.
You may not be if
Clinical and/or radiographic (MRI) progression of tumor following external beam radiation therapy.
Metastatic disease.
Untreated symptomatic hydrocephalus determined by treating physician.
AST or ALT \> 2x the upper limit of normal.
Platelets \< 100,000/mcL.
ANC \< 1000/mcL.
Abnormal PT (Inr) \>1.5 INR or PTT \> 42 sec (may be corrected with FFP, cryoprecipitate, vitamin K, etc).
Total bilirubin \> 2.0 mg/dl.
Serum creatinine \> 1.5x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR \< 70 ml/min/1.73 m2.
