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Clinical Trials
at UNC Treating Newly Diagnosed
Glioblastoma
A Phase II
Clinical Trial Evaluating DCVax®-Brain,
Autologous Dendritic Cells Pulsed with Tumor
Lysate Antigen for the Treatment of Glioblastoma
Multiforme
The
study is designed as a randomized,
placebo-controlled, double blinded,
multi-center, Phase II clinical trial. Patients
with newly diagnosed grade 4 astrocytoma, who
underwent the surgery will be eligible for the
study. Patients will receive either DCVax-Brain
as adjuvant therapy to standard treatment or
standard treatment supplemented with autologous
PBMC (placebo).
An
additional, separate informational arm will be
composed of patients who display progressive GBM
at completion of radiation/chemo-therapy, or who
are otherwise determined to be ineligible for
the investigational arm of the study after
leukapheresis.
BTTC11-01:
Randomized, Double-Blind, Placebo-Controlled
Trial of Lacosamide for Seizure Prophylaxis in
Patients with High-Grade
Gliomas
This
is a multicenter, randomized, placebo-controlled
trial to assess the efficacy of prophylactic
administration of the antiepileptic drug (AED)
Lacosamide in patients with newly-diagnosed
high-grade glioma (HGG).
There
is no consensus among neurologists,
neurosurgeons, and oncologists regarding the
need for prophylactic AEDs among newly-diagnosed
and peri-operative HGG patients who have not
experienced seizures. Addressing an important
question in the field of neuro-oncology, the
primary objective of this study is to determine
if prophylactic administration of Lacosamide
reduces the risk of seizures in patients with
HGG. This will be tested in
newly-diagnosed post-operative patients during
the first year after tumor
diagnosis. |