Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
NCT ID: NCT00600054
Last Updated: 2011-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2007-10-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
nimotuzumab (anti EGFR humanized monoclonal antibody)
150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity.
Interventions
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nimotuzumab (anti EGFR humanized monoclonal antibody)
150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity.
Eligibility Criteria
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Inclusion Criteria
* Patients with recurrent, diffuse intrinsic pontine gliomas
* Patients should have had 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia and a onset prior to initial diagnosis \< 6 months.
* Evidence of disease progression
* Have a Lansky or Karnofsky Performance Status of \> 40
* Be between the age \>3 years to \< 18 years of age
* Have a tumor that is measurable radiologically
* For female patients of childbearing age: presence of a negative pregnancy test within 7 days prior to day 0.
* Use of effective contraception
* Adequate hematological, renal, and hepatic function
Exclusion Criteria
* More than one line of treatment
* Patients with disseminated disease are not eligible
* Had radiation therapy completed within 12 weeks of enrollment
* Previous chemotherapy completed \< 2 weeks prior to enrollment
* If female, is pregnant or lactating
* Has other existing serious medical conditions
* Has any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives
* Is currently taking or planning to take other investigational drugs during the study
* Known contraindications against antibodies
3 Years
18 Years
ALL
No
Sponsors
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YM BioSciences
INDUSTRY
Responsible Party
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YM BioSciences Inc.
Principal Investigators
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Eric Bouffet, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Ute Bartels, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Sylvain Baruchel, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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Children's Hospital/University of Colorado
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., 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 Litwinsky, Tel-Hashomer, Israel
Countries
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Other Identifiers
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YMB1000-013
Identifier Type: -
Identifier Source: org_study_id
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