A Phase I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme
The study design is multi-centered and non-randomized. Patients with newly diagnosed GBM
undergoing initial surgical resection will be candidates for this study. Eligible patients
will undergo surgical resection within 30 days of diagnosis.
Newly diagnosed patients with presumed diagnosis of GBM will undergo surgery for maximal
resection. After frozen section diagnosis of GBM is confirmed, the GliaSite® will be placed
into the tumor cavity.
After the patient recovers from surgery, radiation therapy (60 Gy to 1 cm) is delivered via
the GliaSite®. Radiation therapy with the GliaSite® will be initiated within 21 days after
surgery. Concomitant temozolomide (75 mg/m2/d) is started 2 days prior to radiation therapy
with the GliaSite® and continued for a total of 7 days.
Within 21 days following radiation therapy with the GliaSite®, external beam radiation
therapy (60 Gy in 30 fractions) will be initiated. Concomitant temozolomide (75 mg/m2/d)
will start on day 1 of external beam radiation therapy and continue through the external
beam radiation therapy interval, ending with the last day of radiation.
Four weeks (+/- 2 days) after completion of external beam radiation therapy, temozolomide
(150 mg/m2/d) for 5 days every 28 days will be initiated for one cycle.
At the start of cycle 2, the dose will be escalated to 200 mg/m2/d, if the CTC
non-hematological toxicity for cycle 1 is Grade < 2 (except for alopecia, nausea and
This will continue for up to a total of 12 cycles, unless disease progression or severe
myelosuppression is noted.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Allen K Sills, MD
Methodist University Hospital
United States: Institutional Review Board
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