| > |
Researchers at the University
of Pennsylvania School of Medicine and the Abramson
Cancer Center have
begun ACT III – a Phase II/III Randomized Study – to
investigate the addition of CDX-110 vaccine to standard care
maintenance chemotherapy in patients with newly diagnosed glioblastoma
multiforme (GBM), the most aggressive form of primary brain
tumor. |
| > |
Approximately half of GBM tumors contain
a protein called EGFRvIII, which has only been found in cancer
cells. The purpose of CDX-110 is to “train” the
immune system to recognize EGFRvIII. In patients whose
tumors contain EGFRvIII, this should cause the immune system
to kill the GBM cells. |
| > |
The study will enroll patients 18 years of
age or older with newly diagnosed GBM, and whose tumors contain
EGFRvIII. Enrolled patients will be randomized to receive
either standard of care maintenance chemotherapy with temozolomide,
or standard of care plus injections of CDX-110. |
| > |
The Phase II portion of the ACT III trial
will enroll 90 patients, and if improved disease control is seen
at six months, an additional 285 participants will be enrolled
for the Phase III portion of the trial. |
(PHILADELPHIA) – Researchers at the University
of Pennsylvania School of Medicine and the Abramson
Cancer Center have begun ACT
III – a
Phase II/III Randomized Study – to investigate the addition
of CDX-110
vaccine to standard care maintenance chemotherapy in
patients with newly diagnosed glioblastoma
multiforme (GBM),
the most aggressive form of primary brain
tumor.
CDX-110 (Celldex
Therapeutics, Inc.) is an experimental vaccine
that is being investigated to treat GBM by activating the immune
system to fight the cancer. Approximately half of GBM tumors
contain a protein called EGFRvIII, which has only been found in
cancer cells. The purpose of CDX-110 is to “train” the
immune system to recognize EGFRvIII. In patients whose tumors
contain EGFRvIII, this should cause the immune system to kill the
GBM cells.
“We are excited to begin enrolling patients in this study,
as CDX-110 gets at the genetic cause of these tumors, which could
lead to improved time to progression and overall survival for GBM
patients,” says Donald
M. O’Rourke, MD,
Associate Professor, Department
of Neurosurgery, University of
Pennsylvania School of Medicine.
The study will enroll patients 18 years of age or older with newly
diagnosed GBM, and whose tumors contain EGFRvIII. Enrolled
patients will be randomized to receive either standard of care
maintenance chemotherapy with temozolomide, or standard of care
plus injections of CDX-110.
The Phase II portion of the ACT III trial will enroll 90 patients,
and if improved disease control is seen at six months, an additional
285 participants will be enrolled for the Phase III portion of
the trial.
To learn more about this study at the Penn, contact Joanna Lopinto,
BSN, RN, at (215) 615-4590 or jlopinto@uphs.upenn.edu.
For more information about the study, visit www.celldextherapeutics.com or
call (908) 454-7120, ext. 305.
Editor’s Note: Dr.
O’Rourke has served as a consultant
for Celldex.
###
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