Contact:Sandra Oliphant
Phone:(434)982-0871
E-mail:slo2n@virginia.edu
Malignant gliomas are the most common type of primary brain tumors affecting about 16,000 new patients every year within the United States. The term malignant glioma comprises grade III tumors (anaplastic forms of astrocytoma, oligoastrocytoma, & oligo-dendroglioma) and grade IV tumors (glioblastoma multiforme [GBM]). Malignant gliomas are usually treated with surgery, radiation therapy, and chemotherapy.
Grade III tumors have a better prognosis than GBM tumors, which are very difficult to treat and often recur within several months of treatment. Grade III tumor offers a median overall survival rate of 2-5 years; Grade III tumors account for 5 10% of all malignant gliomas. GBMs are the most common malignant glioma, and are the second leading cause of death from cancer 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 apart from radiotherapy 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 oral medicine called BIBW 2992. In the initial phase of the study (phase I), all patients will receive both Temodar and BIBW 2992. In the second phase of the study, BIBW 2992 will be given alone, with Temodar, or Temodar alone. 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 IV glioblastoma at first recurrence only, or Grade III/IV malignant glioma (phase I only portion of this study) during any recurrence. The diagnosis must be based on a surgical specimen of the tumor (which may be from the original diagnostic surgery/biopsy).
" Have evidence of tumor progression by MRI after completing radiation & chemotherapy
" Have completed radiation therapy 12 or more weeks before study enrollment.
" 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 Bevacizumab within the last 4 weeks
" Progressive disease or dose limiting toxicity to Temodar
" Prior EGFR-directed therapy (phase 2 only portion of this study)
" Chronic diarrhea or other GI disorders that may interfere with study drug absorption
" 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: Sandra Oliphant
Phone: (434) 243-9360
Email: slo2n@virginia.edu
Primary Investigator: David Schiff, MD
Accepts adult enrollment: YES
IRB-HSR# 13747
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Primary Investigator: Schiff David,