Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Mu… (NCT00387400) | Clinical Trial Compass
CompletedPhase 1
Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme
Canada32 participantsStarted 2007-03-20
Plain-language summary
RATIONALE: 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. 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. Giving temozolomide together with everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with temozolomide in treating patients with newly diagnosed, recurrent, or progressive malignant glioblastoma multiforme.
Who can participate
Age range18 Years – 120 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed malignant glioblastoma multiforme, meeting 1 of the following criteria:
* Newly diagnosed disease AND meets the following criteria:
* Has undergone prior surgery and radiotherapy with concurrent temozolomide
* No prior chemotherapy except for concurrent low-dose temozolomide given with radiotherapy
* Recurrent or progressive disease after front-line therapy AND meets the following criteria:
* No more than 1 prior chemotherapy regimen in the adjuvant setting
* More than 4 months since last adjuvant treatment
* No prior chemotherapy for recurrence
* Bidimensionally measurable disease, defined as ≥ 1 enhancing lesion ≥ 1 cm x 1 cm by CT scan or MRI, within 21 days of study entry (for patients with recurrent/relapsed disease)
* Patients receiving steroids must be on stable dose for at least 14 days before baseline CT scan or MRI
* Paraffin-embedded sample of primary or metastatic tumor diagnostic specimen must be available
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Absolute granulocyte count ≥ 1,500/mm³
* Platelet count ≥ 120,000/mm³
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No upper gastrointestinal condition or other condition that would preclude compliance with oral m…
What they're measuring
1
Safety and tolerability of everolimus as measured by NCI CTCAE v3.0