CompletedPhase 1/2

Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

United States279 participantsStarted 2010-12

Plain-language summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Giving everolimus together with temozolomide and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with temozolomide and radiation therapy and to see how well it works in treating patients with newly diagnosed glioblastoma multiforme.

Who can participate

Age range18 Years – 120 Years

SexALL

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Inclusion criteria

✓. Histologically proven diagnosis of glioblastoma (WHO grade IV) confirmed by central pathology review prior to Step 2 registration. Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis.
✓. Tumor tissue available for correlative studies (Required only in phase II portion, as described below).
✓. The tumor must have a supratentorial component
✓. Patients must have recovered from the effects of surgery, postoperative infection, and other complications.
✓. A diagnostic contrast-enhanced MRI or CT scan (if MRI is not available due to non-compatible devices) of the brain must be performed preoperatively and postoperatively. The postoperative scan must be done within 28 days prior to step 2 registration, ,preferably within 96 hours of surgery. Preoperative and postoperative scans must be the same type.
✓. History/physical examination within 14 days prior to step 2 registration
✓. Neurologic examination within 14 days prior to step 2 registration
✓. Documentation of steroid doses within 14 days prior to step 2 registration

Exclusion criteria

What they're measuring

Phase I: Number of Patients With Dose-limiting Toxicity (DLT)

Timeframe: From start of treatment to eight weeks.

Phase II: Progression-free Survival (PFS)

Timeframe: Analysis occured after 134 events (progression or death) were reported. Patients were followed from randomization to death or study termination whichever occurs first, up to 36.7 months.

Trial details

NCT IDNCT01062399

SponsorRadiation Therapy Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2017-11-13

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