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Tracking Information | |
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First Received Date † | October 24, 2006 |
Last Updated Date | May 13, 2009 |
Start Date † | June 2006 |
Current Primary Outcome Measures † |
Survival at six months of treatment without evidence of disease progression. [ Time Frame: 6 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00392171 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
Overall clinical benefit; Tumor response; Time to objective response; Duration of objective response; Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | The Effects of Continuous 28-Day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-Day (5/28) Treatment (P04601AM1)(COMPLETED) |
Official Title † | The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-Intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma |
Brief Summary | The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m2). |
Detailed Description | |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Condition † |
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Intervention † | Drug: Temozolomide |
Study Arms / Comparison Groups | Experimental: Temozolomide will be administered at a dose of 50mg/m2 for cycles of 28 days for 12 months or until progression. |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Estimated Enrollment † | 90 |
Completion Date | February 2009 |
Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 19 Years to 70 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00392171 |
Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
Secondary IDs †† | |
Study Sponsor † | Schering-Plough |
Collaborators †† | Schering Canada, Inc. |
Investigators † | |
Information Provided By | Schering-Plough |
Verification Date | May 2009 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |