Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | October 12, 2006 | ||||
Last Updated Date | February 13, 2009 | ||||
Start Date † | July 2006 | ||||
Current Primary Outcome Measures † |
Safety and tolerability of everolimus as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00387400 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
|
||||
Original Secondary Outcome Measures † |
|
||||
Descriptive Information | |||||
Brief Title † | Temozolomide and Everolimus in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme | ||||
Official Title † | A Phase I Study of Temozolomide and RAD001C in Patients With Malignant Glioblastoma Multiforme | ||||
Brief 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. |
||||
Detailed Description | 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. |
||||
Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label | ||||
Condition † | Brain and Central Nervous System Tumors | ||||
Intervention † |
|
||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 30 | ||||
Completion Date | |||||
Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00387400 | ||||
Responsible Party | |||||
Secondary IDs †† | CAN-NCIC-IND162 | ||||
Study Sponsor † | National Cancer Institute of Canada | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |