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Sponsored by: |
National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00387400 |
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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: everolimus Drug: temozolomide Procedure: adjuvant therapy Procedure: gene expression profiling Procedure: immunohistochemistry staining method Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I Study of Temozolomide and RAD001C in Patients With Malignant Glioblastoma Multiforme |
Estimated Enrollment: | 30 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, nonblinded, parallel-group, multicenter, dose-escalation study of everolimus. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (yes vs no).
Patients receive oral temozolomide once daily on days 2-5 in course 1 and on days 1-5 in all subsequent courses. Patients also receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with newly diagnosed disease receive up to 6 courses of treatment. Patients with recurrent disease who achieve a response (partial or complete response) or stable disease may continue treatment until disease progression or unacceptable toxicity.
Cohorts of 3-6 patients per stratum receive escalating doses of everolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of therapy. Once the MTD is determined, an additional 6 patients are treated at the MTD.
Patients' archival diagnostic tumor tissue is evaluated during study for correlative molecular studies (by immunohistochemical staining) of mammalian target of rapamycin inhibition status (mTOR activity) and pretreatment molecular markers. Blood samples are taken periodically during course 1 for pharmacokinetic studies.
After completion of study therapy, patients are followed at 4 weeks. Patients with stable or responding disease are then followed every 3 months until relapse or progression.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioblastoma multiforme, meeting 1 of the following criteria:
Newly diagnosed disease AND meets the following criteria:
Recurrent or progressive disease after front-line therapy AND meets the following criteria:
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)
PATIENT CHARACTERISTICS:
No serious illness or underlying medical condition that would preclude study compliance, including any of the following:
PRIOR CONCURRENT THERAPY:
Canada, Alberta | |
Cross Cancer Institute at University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Dorcas Fulton 780-432-8517 | |
Tom Baker Cancer Centre - Calgary | Recruiting |
Calgary, Alberta, Canada, T2N 4N2 | |
Contact: Jacob Easaw 403-521-3446 | |
Canada, British Columbia | |
British Columbia Cancer Agency - Centre for the Southern Interior | Recruiting |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
Contact: Delia Sauciuc 250-712-3900 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Brian Thiessen 604-877-6000 | |
Canada, Nova Scotia | |
Nova Scotia Cancer Centre | Recruiting |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Contact: Mary MacNeil 902-473-8317 | |
Canada, Ontario | |
London Regional Cancer Program at London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 4L6 | |
Contact: David R. MacDonald 519-685-8640 | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Contact: Warren Mason 416-946-2277 | |
Canada, Quebec | |
Hopital Notre-Dame du CHUM | Recruiting |
Montreal, Quebec, Canada, H2L 4M1 | |
Contact: Karl Belanger 514-890-8200 | |
McGill Cancer Centre at McGill University | Recruiting |
Montreal, Quebec, Canada, H2W 1S6 | |
Contact: Petr Kavan 514-398-1444 |
Study Chair: | Warren P. Mason, MD | Princess Margaret Hospital, Canada |
Study ID Numbers: | CDR0000507616, CAN-NCIC-IND162 |
Study First Received: | October 12, 2006 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00387400 |
Health Authority: | Unspecified |
adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor adult glioblastoma |
Everolimus Glioblastoma Astrocytoma Central Nervous System Neoplasms Temozolomide Recurrence Brain Neoplasms Neuroectodermal Tumors |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents |