Spots Global Cancer Trial Database for Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
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Trial Identification
Brief Title: Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
Official Title: Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma
Study ID: NCT00600054
Conditions
Study Description
Brief Summary: This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. Patients are eligible without histologic confirmation. Treatment regimen will consist of two phases-induction and consolidation.
Detailed Description:
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital/University of Colorado, Denver, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Children's Memorial Hospital, Chicago, Illinois, United States
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins, Baltimore, Maryland, United States
NYU Medical Center, Hassenfeld Clinic, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of Rochester Medical Center, Strong Memorial Hospital, Rochester, New York, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The University of Texas/M.D. Anderson Cancer Center, Houston, Texas, United States
Alberta Children's Hospital, Calgary, Alberta, Canada
The Hospital For Sick Children, Toronto, Ontario, Canada
The Chaim Sheba Medical Center, Tel-Hashomer, , Israel
Contact Details
Name: Eric Bouffet, MD
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR
Name: Ute Bartels, MD
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR
Name: Sylvain Baruchel, MD
Affiliation: The Hospital for Sick Children
Role: PRINCIPAL_INVESTIGATOR
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