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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00650923 |
Purpose
RATIONALE: Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. 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. Giving aflibercept together with radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of aflibercept when given together with radiation therapy and temozolomide in treating patients with newly diagnosed or recurrent glioblastoma multiforme, gliosarcoma, or other malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: aflibercept Drug: temozolomide Genetic: DNA methylation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis Other: pharmacological study Procedure: adjuvant therapy Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Aflibercept (VEGF Trap) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Malignant Glioma |
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | June 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 intracranial glioblastoma multiforme or gliosarcoma
No evidence of significant intratumoral or peritumoral hemorrhage on pre-operative MRI or a large amount of peri-operative parenchymal hemorrhage on post-operative MRI
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease within the past 6 months, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent full-dose anticoagulants (e.g., warfarin or low molecular-weight heparin)
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
| Study Chair: | John F. deGroot, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Director, ABTC, Adult Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00650923 History of Changes |
| Other Study ID Numbers: | CDR0000590174, U01CA062399, ABTC-0701, NABTC-0701 |
| Study First Received: | April 1, 2008 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult anaplastic astrocytoma |
adult anaplastic oligodendroglioma adult mixed glioma recurrent adult brain tumor |
|
Glioblastoma Glioma Nervous System Neoplasms Central Nervous System Neoplasms Gliosarcoma Astrocytoma 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 Adjuvants, Immunologic Temozolomide Dacarbazine Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |