A Phase I Trial of Nanoliposomal CPT-11 (NL CPT-11) in Patients With Recurrent High-Grade Gliomas
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase I study of Nanoliposomal CPT-11 in patients with Recurrent high-grade
gliomas. Patients must have a histologically proven intracranial malignant glioma, which
includes glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA),
anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant
astrocytoma NOS (not otherwise specified). Patients who are wild type or heterozygous for the
UGT1A1*28 gene will received Nanoliposomal CPT-11. The total anticipated accrual will be
approximately 36 patients (depending upon the actual MTD). The investigators hypothesis is
that this new formulation of CPT-11 will increase survival over that seen in historical
controls who have recurrent gliomas because CPT-11 will be encapsulated in a liposome
nanoparticle, which has been seen to reduce toxicities from the drug.