Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 20, 2007

Primary Completion Date

September 24, 2010

Study Completion Date

January 6, 2012

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

everolimus

150 mg/m2/day PO Daily x 5, q 4 weeks

DRUG

temozolomide

2.5 mg PO Daily, beginning day 2 of cycle 1, q 4 weeks

GENETIC

microarray analysis

Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.

OTHER

immunohistochemistry staining method

Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.

Trial Locations (9)

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V1Y 5L3

BCCA - Cancer Centre for the Southern Interior, Kelowna

V5Z 4E6

BCCA - Vancouver Cancer Centre, Vancouver

B3H 1V7

QEII Health Sciences Center, Halifax

N6A 4L6

London Regional Cancer Program, London

M5G 2M9

Univ. Health Network-Princess Margaret Hospital, Toronto

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

H2W 1S6

McGill University - Dept. Oncology, Montreal

Sponsors
All Listed Sponsors
lead

NCIC Clinical Trials Group

NETWORK