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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Pfizer |
Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00606008 |
We are asking patients to take part in this study because they have recurrent (returned) (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM).
The purposes of this study are:
Sutent will be administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break. Neurologic and neuroradiographic evaluations will be performed every 6 weeks to assess for response.
Condition | Intervention | Phase |
Anaplastic Astrocytoma Glioblastoma |
Drug: Sunitinib Malate |
Phase II |
MedlinePlus related topics: | Cancer |
Drug Information available for: | Sunitinib Sunitinib malate Malic acid |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme |
Estimated Enrollment: | 55 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental |
Drug: Sunitinib Malate
A prospective Phase 2 trial of SU011248 in patients with recurrent (1st or 2nd) anaplastic astrocytoma (AA) or glioblastoma (GBM). A single dose of SU011248 will be utilized based on prior experience with this agent. As the metabolism of SU011248 may be effected hepatic enzyme inducing anticonvulsant drugs (AED), an issue with a variety of other chemotherapeutics, all patients will be treated with non-enzyme inducing AEDs. 55 patients will be stratified based upon tumor histology [2 strata, one each for AA and GBM].
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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function as defined by the following criteria:
Exclusion Criteria:
Contact: Sajeel Chowdhary, M.D. | 813-4-745-4673 | sajeel.chowdhary@moffitt.org |
United States, Florida | |||||
H. Lee Moffitt Cancer Center and Research Institute | Recruiting | ||||
Tampa, Florida, United States, 33612 | |||||
Contact: Sajeel Chowdhary, M.D. 813-745-4673 sajeel.chowdhary@moffitt.org | |||||
Principal Investigator: Sajeel Chowdhary, M.D. | |||||
Sub-Investigator: Clifford Schold, M.D. | |||||
Sub-Investigator: Edward Pan, M.D. |
H. Lee Moffitt Cancer Center and Research Institute |
Pfizer |
Principal Investigator: | Sajeel Chowdhary, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Moffitt Cancer Center Clinical Trials website 
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Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Sajeel Chowdhary, M.D. ) |
Study ID Numbers: | MCC-14916, USFIRB#105192 |
First Received: | January 21, 2008 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00606008 |
Health Authority: | United States: Institutional Review Board |
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