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Sponsors and Collaborators: |
Massachusetts General Hospital National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00662506 |
RATIONALE: Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cediranib together with temozolomide and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of cediranib to see how well it works when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: cediranib maleate Drug: temozolomide Procedure: adjuvant therapy Procedure: diffusion tensor imaging Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: intensity-modulated radiation therapy Procedure: laboratory biomarker analysis Procedure: proteomic profiling |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase Ib/II Study of AZD2171 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma Not Taking Enzyme-Inducing Anti-Epileptic Drugs |
Estimated Enrollment: | 80 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma
PATIENT CHARACTERISTICS:
Must be able to tolerate MRI and must consent to participate in additional Vascular Imaging Procedures per protocol
No concurrent malignancy except curatively treated basal cell or squamous cell carcinoma skin cancer or carcinoma in situ of the cervix or breast
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior and no concurrent enzyme-inducing anti-epileptic drugs (EIAEDs)
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Patrick Y. Wen, MD 617-632-2166 patrick_wen@dfci.harvard.edu | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 |
Study Chair: | Tracy Batchelor, MD, MPH | Massachusetts General Hospital |
Study ID Numbers: | CDR0000593717, MGH-07-344 |
Study First Received: | April 18, 2008 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00662506 |
Health Authority: | Unspecified |
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma |
Neuroectodermal Tumors Glioblastoma Astrocytoma Epilepsy Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Central Nervous System Neoplasms Gliosarcoma Temozolomide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |