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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00521482 |
The aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide treatment alone in parallel to a combination with thalidomide in patients with recurrent glioblastoma after standard therapy.
In the treatment arm A of the study it will be investigated whether or not continuous dosing of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress on the 5/28 day dosing regimen.
For treatment arm B it is postulated that the combination of thalidomide and temozolomide is effective with respect to time to progression and progression-free survival due to the fact that temozolomide and thalidomide have different mechanisms of action.
Condition | Intervention | Phase |
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Glioblastoma |
Drug: Temozolomide Drug: Temozolomide plus Thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial |
Estimated Enrollment: | 40 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
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A: Active Comparator
Temozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression.
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Drug: Temozolomide |
B: Experimental
Temozolomide 200 mg/m2 for 5 days during each 28-day cycle plus Thalidomide 100 mg for 2 weeks, thereafter 200 mg daily continuously until tumor progression.
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Drug: Temozolomide plus Thalidomide |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Miroslava Bjeljac, MD | 0041 44 255 23 96 | Miroslava.Bjeljac@usz.ch |
Switzerland | |
University Zurich, Departement of Neurosurgery | |
Zurich, Switzerland, 8091 |
Principal Investigator: | Miroslava Bjeljac, MD | University of Zurich |
Study ID Numbers: | TMZ/05, P04932 |
Study First Received: | August 27, 2007 |
Last Updated: | August 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00521482 |
Health Authority: | Switzerland: Swissmedic |
recurrent after standard therapy |
Neuroectodermal Tumors Glioblastoma Dacarbazine Thalidomide Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Temozolomide Recurrence Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors |
Pharmacologic Actions Anti-Bacterial Agents Neoplasms Therapeutic Uses Antineoplastic Agents, Alkylating Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Neuroepithelial Alkylating Agents Leprostatic Agents |