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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00679354 |
RATIONALE: Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: cilengitide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma |
Estimated Enrollment: | 24 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years and then periodically for 3 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* primary CNS high-grade glioma, including any of the following:
Radiographically documented measurable disease
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine based on age/gender as follows:
PRIOR CONCURRENT THERAPY:
At least 6 months since prior allogeneic stem cell transplantation (SCT) or rescue
Study Chair: | Tobey MacDonald, MD | Childrens Research Institute |
Study ID Numbers: | CDR0000595623, COG-ACNS0621 |
Study First Received: | May 14, 2008 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00679354 |
Health Authority: | Unspecified |
recurrent childhood brain stem glioma childhood high-grade cerebellar astrocytoma childhood high-grade cerebral astrocytoma recurrent childhood cerebral astrocytoma |
recurrent childhood cerebellar astrocytoma childhood oligodendroglioma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood brain tumor |
Neuroectodermal Tumors Brain Neoplasms Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma |
Glioma Central Nervous System Neoplasms Recurrence Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |