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Sponsors and Collaborators: |
Rigshospitalet, Denmark GCP-Unit, Copenhagen Wyeth Roche, Copenhagen |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00800917 |
This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomid and VEGF-directed therapy with Bevacizumab will be considered for the study. Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A safety analysis will be performed when the first 10 patients have received minimum 4 cycles (8 weeks). The study will then be stopped: If DLT is observed in > 2/10 patients, Occurrence of any serious adverse events not described in the SPC of each agents, If partial remission is not observed in at least 1/10 patients
Condition | Intervention | Phase |
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Glioblastoma Multiforme |
Drug: Temsirolimus Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Official Title: | A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following:
Exclusion Criteria:
Contact: Ulrik Lassen, MD, PH.D. | +45 35453545 |
Denmark | |
Rigshospitalet | Recruiting |
Copenhagen, Denmark | |
Contact: Ulrik Lassen, MD, PH.D | |
Principal Investigator: Ulrik Lassen, MD, PH.D |
Study ID Numbers: | BEV-CCI-779-GBM-02, Eudract no.: 2008-003679-40 |
Study First Received: | December 1, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00800917 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Neuroectodermal Tumors Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Bevacizumab |
Glioblastoma Multiforme Glioma Angiogenesis Inhibitors Recurrence Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Astrocytoma Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Bevacizumab Angiogenesis Inhibitors Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Growth Inhibitors Glioma Angiogenesis Modulating Agents Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |