Category: Neurology, Cancer (Oncology), HIC#13467
Title:
PHASE 2, 2-PART, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CT-322 (ANGIOCEPT") MONOTHERAPY AND COMBINATION THERAPY WITH IRINOTECAN IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME
Contact:Goga Radakovic
Phone:(434)243-5750
E-mail:gr2p@virginia.edu

Glioblastoma multiforme (GBM) is a type of brain tumor that is cancerous. The usual treatments include surgery, radiation therapy, and chemotherapy. Unfortunately, these tumors are very difficult to treat and often recur within several months of treatment. GBMs are the second leading cause of death from cancers in people under the age of 35 and the fourth leading cause under the age of 54. There is no known cure for recurrent glioblastomas and there are no therapies available that have been proven to prolong survival by more than two months on average.
The purpose of this study is to look at survival rate of those treated with an investigational medicine called CT-322. Participants will have a routine history and physical exam performed, tumor evaluations by magnetic resonance imaging (MRI), and routine blood tests.

You may qualify for the study if you:

" Are a male or non-pregnant female age 18 or older

" Have grade 4 glioblastoma at first,second, or third recurrence. The diagnosis must be confirmed by previous lab tests.

" Have evidence of tumor progression by MRI after completing radiation and chemotherapy

" Have completed radiation therapy 12 or more weeks before study enrollment.

" Had 3 or less prior chemotherapy regimens for your tumor

" Are on a stable or decreasing dose of corticosteroids for 1 week prior to baseline MRI.

" Are willing to practice effective method of birth control during study participation

You may not qualify for this study if you have/had/are:

" Other active cancers requiring therapy to control disease

" Receiving any other investigational agents

" Received prior therapy with CT-322

" Received prior treatment including, but not limited Avastin®, PTK-787, Nexavar®, Sutent®, AZD2171,

" Unstable systemic disease, including active infection, uncontrolled hypertension, or serious cardiac arrhythmia requiring medication

" Pregnant women or nursing women

You will not receive payment for participating in this study.

For more information or to see if you qualify, please contact:

Contact: Goga Radakovic
Phone: (434) 243-5750
Email: gr2p@virginia.edu

Primary Investigator: David Schiff, MD Accepts adult enrollment: YES
IRB-HSR# 13467

Primary Investigator: Schiff David,
Department: Neurology
Accepts adult enrollment :YES
Accepts minor enrollment :NO