Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00369590 |
RATIONALE: VEGF Trap may stop the growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well VEGF Trap works in treating patients with recurrent malignant or anaplastic gliomas that did not respond to temozolomide.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Biological: aflibercept |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Single Arm Trial of VEGF Trap in Patients With Recurrent Temozolomide-Resistant Malignant Gliomas |
Estimated Enrollment: | 45 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to histology (glioblastoma vs anaplastic glioma).
Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Patients presenting at the time of first recurrence or relapse, defined as progression after initial therapy (i.e., radiotherapy +/- chemotherapy if that was used as initial therapy) are eligible
Prior surgical, interstitial brachytherapy, or stereotactic radiosurgery not considered prior therapy
Recent resection of recurrent or progressive tumor allowed
Must have failed prior treatment with temozolomide
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
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 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-6220 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | John F. deGroot, MD | M.D. Anderson Cancer Center |
Responsible Party: | Adult Brain Tumor Consortium ( Michael Prados ) |
Study ID Numbers: | CDR0000495275, ABTC-0601, NABTC-0601 |
Study First Received: | August 24, 2006 |
Last Updated: | July 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00369590 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult giant cell glioblastoma adult gliosarcoma adult anaplastic oligodendroglioma |
recurrent adult brain tumor adult anaplastic astrocytoma adult mixed glioma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Temozolomide Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Antineoplastic Agents, Alkylating Glioma Gliosarcoma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Temozolomide Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |