Glioblastoma Research Study

IRB-HSR# 12421
Service: Cancer, Neurosciences | Category: Neurology, Cancer
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: David Schiff, M.D.

Contact Information

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

Clinical Trial Description

Glioblastoma multiforme (GBM) is a type of malignant brain tumor. The usual treatments include surgery, radiation therapy, and chemotherapy. Unfortunately, these tumors are relatively resistant to standard 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 under the age of 54. Recurrent glioblastomas remain incurable, and to date no specific therapy has been shown to prolong survival by more than two months on average.

In this study, researchers will be looking at the survival rate of patients treated with two investigational medicines, one called Sorafenib (Nexavar) and another called Temsirolimus (CCI-779). 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 is you:

• Are a male or non-pregnant female age 18 or older
• Have had histological confirmation of a grade 4 astrocytoma or gliosarcoma at primary diagnosis and/or recurrence
• Have evidence of tumor progression by MRI or CT scan following radiation therapy RT or following the most recent anti-tumor therapy
• Completed RT more than e12 weeks before study enrollment
• Have measurable or evaluable tumor on MRI or CT scan
• You are on stable dose of corticosteroids (or no corticosteroids) e1 week prior to registration
• You had < 2 chemotherapy regimens for recurrence of your tumor
• 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
• Receiving any other investigational agents
• Prior intratumoral chemotherapy (e.g. Gliadel or IL13-PE38QQR), stereotactic radiosurgery or interstitial brachytherapy
• Pregnant women or nursing women
• Are receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, fosphenytoin, carbamazepine, oxcarbazepine, phenobarbital, or primidone)

Compensation

You will not receive payment for participating in this study.