|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00662506 |
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: cediranib maleate Drug: temozolomide Genetic: proteomic profiling Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: diffusion tensor imaging Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging Radiation: fludeoxyglucose F 18 Radiation: intensity-modulated radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: 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) |
Show Detailed Description
Eligibility| 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 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)
No concurrent anticoagulants (e.g., dalteparin, warfarin, or low-molecular weight heparin)
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Tracy Batchelor, MD, MPH | Massachusetts General Hospital |
More Information
| Responsible Party: | Tracy Batchelor, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00662506 History of Changes |
| Other Study ID Numbers: | CDR0000593717, MGH-07-344, PHS 398/2590 |
| Study First Received: | April 18, 2008 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Anticonvulsants Temozolomide Dacarbazine Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |