Nervous System Disorders

Category: Neurology, Cancer (Oncology), HIC#13988
Title:
PHASE 1, OPEN LABEL, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF CT-322 ADMINISTERED IN COMBINATION WITH FOCAL BRAIN RADIOTHERAPY AND TEMOZOLOMIDE TO SUBJECTS WITH NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (DXS003)
Contact:Yuliya Havaleshko
Phone:(434)243-9900
E-mail:yih8f@virginia.edu

UVa Health System seeks adults with Glioblastoma for research study

Glioblastoma (GBM) is a kind of brain tumor. The usual treatments are: surgery, radiation therapy and Temozolomide chemotherapy. Unfortunately, these tumors are resistant to most treatments and typically recur within months of treatment. These tumors are the second leading cause of death from cancers in people under the age of 35 and the fourth leading cause in those under the age of 54. There is no cure for this kind of tumor, and many people with this tumor die in 12-15 months.

In this study, researchers will be looking at the survival rate of those treated with an investigational medicine called CT-322 in combination with standard radiation treatment and the standard chemotherapeutic agent Temozolomide. Participants will have tumor evaluations done by magnetic resonance imaging (MRI), routine physical exam and blood tests during clinic visits.

You may qualify for the study is you:
" Are a male or non-pregnant female age 18 or older
" Have had surgical biopsy or surgical removal of the tumor. (Note: you must be able to enroll and begin treatment with RT/TMZ within 6 weeks after biopsy or surgery)
" Are willing to practice effective method of birth control during study participation

You may not qualify for this study if you have/had:
" Other active cancers requiring therapy to control disease
" Prior chemotherapy or radiation therapy for any brain tumor
" Had any prior anti-tumor treatment (other than corticosteroids) including any investigational agents

OR you are
" Receiving any other investigational agents
" Pregnant, breastfeeding or intend to become pregnant during your participation

You will not receive payment for participation in this study.

For more information or to see if you qualify, please contact:
Yuliya Havaleshko, MD
Phone: 434-243-9900 Email: yih8f@virginia.edu

Principal Investigator: David Schiff, MD
HIC #13988


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