Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme
NCT00890032 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2016-10-17
Summary
RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).
Conditions
- Recurrent Central Nervous System Neoplasm
Interventions
- BIOLOGICAL
-
BTSC mRNA-loaded DCs
An escalating total dose of BTSC mRNA-loaded DCs (2x10\^6, 5x10\^6, and 2x10\^7 per vaccination) will be evaluated for purpose of establishing a maximum tolerated dose (MTD) and a dose-limiting toxicity (DLT).
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
John Sampson
lead OTHER
Principal Investigators
-
Gordana Vlahovic, MD · Duke University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2014-10-31
- Completion
- 2016-02-29
Countries
- United States
Study Locations
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