NCT00387400

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

Completed Phase 1 Last updated 4 August 2023

What this trial tests

Phase 1 trial testing everolimus in Brain and Central Nervous System Tumors in 32 participants. Completed in 6 January 2012.

Timeline

20 March 2007

Primary endpoint
24 September 2010

6 January 2012

Quick facts

Lead sponsor	NCIC Clinical Trials Group
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	20 March 2007
Primary completion	24 September 2010
Estimated completion	6 January 2012
Sites	9 locations across Canada

Drugs / interventions tested

• everolimus (everolimus) — full drug profile →
• temozolomide (temozolomide) — full drug profile →
• microarray analysis
• immunohistochemistry staining method

Conditions studied

• Brain and Central Nervous System Tumors — all drugs for Brain and Central Nervous System Tumors →

Sponsor

NCIC Clinical Trials Group

Who can join

Adults 18 to 120, any sex, with Brain and Central Nervous System Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PI3K/Akt/mTOR signaling pathway and targeted therapy for glioblastoma.
   Li X, Wu C, Chen N, Gu H, et al · · 2016 · cited 406× · PMID 26967052 · DOI 10.18632/oncotarget.7961
2. Combined inhibition of AKT/mTOR and MDM2 enhances Glioblastoma Multiforme cell apoptosis and differentiation of cancer stem cells.
   Daniele S, Costa B, Zappelli E, Da Pozzo E, et al · · 2015 · cited 68× · PMID 25898313 · DOI 10.1038/srep09956
3. Experimental approaches for the treatment of malignant gliomas.
   Arko L, Katsyv I, Park GE, Luan WP, et al · · 2010 · cited 65× · PMID 20546782 · DOI 10.1016/j.pharmthera.2010.04.015
4. The mTOR signaling pathway as a treatment target for intracranial neoplasms.
   Pachow D, Wick W, Gutmann DH, Mawrin C. · · 2015 · cited 46× · PMID 25165193 · DOI 10.1093/neuonc/nou164
5. Unveiling Novel Avenues in mTOR-Targeted Therapeutics: Advancements in Glioblastoma Treatment.
   Singh S, Barik D, Lawrie K, Mohapatra I, et al · · 2023 · cited 12× · PMID 37834408 · DOI 10.3390/ijms241914960
6. Discrete Mechanistic Target of Rapamycin Signaling Pathways, Stem Cells, and Therapeutic Targets.
   Jhanwar-Uniyal M, Zeller SL, Spirollari E, Das M, et al · · 2024 · cited 8× · PMID 38474373 · DOI 10.3390/cells13050409
7. Targeted therapy in the treatment of malignant gliomas.
   Lukas RV, Boire A, Nicholas MK. · · 2009 · cited 4× · PMID 20616900 · DOI 10.2147/ott.s3027
8. The Role of mTOR Signaling in Tumor-Induced Alterations to Neuronal Function in Diffusely Infiltrating Glioma.
   Haile H, Leskinen S, Adapa AR, R Goldberg A, et al · · 2025 · cited 2× · PMID 41301687 · DOI 10.3390/biomedicines13112593