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| Sponsors and Collaborators: |
Pediatric Brain Tumor Consortium National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00063973 |
Purpose
RATIONALE: Cilengitide may slow the growth of brain cancer cells by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of cilengitide in treating children with recurrent, progressive, or refractory primary CNS tumors.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors |
Drug: cilengitide |
Phase I |
| MedlinePlus related topics: | Brain Cancer Cancer Childhood Brain Tumors |
| Drug Information available for: | Cilengitide |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Cilengitide (EMD 121974) in Children With Refractory Brain Tumors |
| Study Start Date: | July 2003 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive cilengitide (EMD 121974) IV over 1 hour twice weekly. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of cilengitide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 25% of patients are expected to experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients are accrued and treated at that dose level.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1-1.5 years.
Eligibility
| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary central nervous system (CNS) tumor, including histologically benign CNS tumors (e.g., low-grade gliomas)*
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |||||
| UCSF Comprehensive Cancer Center | |||||
| San Francisco, California, United States, 94143 | |||||
| United States, District of Columbia | |||||
| Children's National Medical Center | |||||
| Washington, District of Columbia, United States, 20010-2970 | |||||
| United States, Illinois | |||||
| Children's Memorial Hospital - Chicago | |||||
| Chicago, Illinois, United States, 60614 | |||||
| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
| 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, North Carolina | |||||
| Duke Comprehensive Cancer Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| United States, Pennsylvania | |||||
| Children's Hospital of Philadelphia | |||||
| Philadelphia, Pennsylvania, United States, 19104-4318 | |||||
| Children's Hospital of Pittsburgh | |||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| United States, Tennessee | |||||
| St. Jude Children's Research Hospital | |||||
| Memphis, Tennessee, United States, 38105 | |||||
| United States, Texas | |||||
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | |||||
| Houston, Texas, United States, 77030-2399 | |||||
| United States, Washington | |||||
| Children's Hospital and Regional Medical Center - Seattle | |||||
| Seattle, Washington, United States, 98105 | |||||
| Pediatric Brain Tumor Consortium |
| National Cancer Institute (NCI) |
| Study Chair: | Tobey MacDonald, MD | Childrens Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000305859, PBTC-012 |
| First Received: | July 8, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00063973 |
| Health Authority: | United States: Federal Government |
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