Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma
NCT02022644 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2023-06-29
Summary
This is a single center, dose-toleration study designed to investigate and determine the maximum tolerated dose of nanoliposomal irinotecan in adults with recurrent high-grade glioma when administered directly into the tumor using a process called convection-enhanced delivery (CED).
Conditions
Interventions
- DRUG
-
nanoliposomal irinotecan
The drug named here (nanoliposomal irinotecan) will be used in varying amounts, based on tumor volume.
Sponsors & Collaborators
- collaborator INDUSTRY
-
National Cancer Institute (NCI)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Nicholas Butowski, MD · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-23
- Primary Completion
- 2020-12-31
- Completion
- 2023-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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