Status: Closed
Activation Date: 2006JUL25
Closing Date: 2009JUN01
Phase: I
Description: A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma
Eligibility: Patients with newly diagnosed (no prior chemotherapy permitted) or recurrent (only one prior adjuvant chemo regimen permitted), glioblastoma multiforme (GBM). Bidimensionally measurable disease. Stable dose of steroids. Paraffin embedded tumour sample available for study.
Objective: To assess the toxicity, pharmacokinetics, efficacy, MTD, and RPII dose(s) of RAD001C when given in combination with standard dose of Temozolomide in patients with GBM. Patients receiving enzyme inducing anti-epileptic drugs (EIAEDs) and those not receiving EIAEDs will be studied separately.
Participation: Participation in this study is restricted to invited centres.
Lay Description: The purpose of this study is to find the highest dose of the drug RAD001C that can be given with standard doses of temozolomide without causing very severe side effects that are not tolerable.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I162 | 32 | 6 | 25 | 27 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I162 | 32 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I162 | 32 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |