Status:
COMPLETED
Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
Lead Sponsor:
Y-mAbs Therapeutics
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Brain Cancer
Brain Stem Glioma
Eligibility:
All Genders
2-21 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to deliver an agent call...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01502917
Start Date
December 1 2011
End Date
January 1 2022
Last Update
December 19 2023
Active Locations (2)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10021
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065