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| Sponsored by: |
Schering-Plough |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00684567 |
Purpose
The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.
| Condition | Intervention | Phase |
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Glioblastoma |
Radiation: Radiotherapy Drug: Temozolomide |
Phase II |
| ChemIDplus related topics: | Temozolomide X-Rays |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme |
| Enrollment: | 30 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Single arm: Experimental
It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
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Radiation: Radiotherapy
Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist in a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher.
Drug: Temozolomide
During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.
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Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory test values obtained within 14 days before initiation of administration of temozolomide must satisfy the following criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P04661, JPC-05-351-22 |
| First Received: | May 22, 2008 |
| Last Updated: | May 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00684567 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
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