A Phase I Study of Convection-Enhanced Delivery of 124I-8H9 for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
maximum tolerated dose
Determination that a dose is safe will be made following the treatment of at least 3 but no more than 6 patients at a particular dose level. The dose levels are DL1 (0.25 mCi), DL2 (0.5 mCi), DL3 (0.75 mCi), DL4 (1 mCi) and fallback DL0 (0.125 mCi). An incidence of dose-limiting toxicity (DLT) in the range of 25% is considered acceptable in this population.
2 years
Yes
Mark Souweidane, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
11-011
NCT01502917
December 2011
December 2014
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Weill Medical College of Cornell University | New York, New York 10021 |