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Sponsored by: |
YM BioSciences |
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Information provided by: | YM BioSciences |
ClinicalTrials.gov Identifier: | NCT00600054 |
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.
Condition | Intervention | Phase |
---|---|---|
Recurrent Diffuse Pontine Gliomas |
Biological: nimotuzumab (anti EGFR humanized monoclonal antibody) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma |
Estimated Enrollment: | 40 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Single arm: Experimental |
Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)
150 mg/m2 I.V. (1mg/ml, over 30 to 60 minutes). 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.
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Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leonardo Viana, MD | 905 629-9761 ext 240 | lviana@ymbiosciences.com |
Contact: Jose Cevallos, MD | 905 629-9761 ext 233 | jcevallos@ymbiosciences.com |
United States, Colorado | |
Children's Hospital/University of Colorado | Recruiting |
Denver, Colorado, United States, 80045 | |
Contact: Lia Gore, MD 720-777-4159 lia.gore@uchsc.edu | |
Contact: Pamela Bowry, RN 720 777-4159 bowry.pamela@tchden.org | |
Principal Investigator: Lia Gore, MD | |
Sub-Investigator: Nicholas Foreman, MD | |
United States, Florida | |
University of Florida Shands Cancer Center | Recruiting |
Gainesville, Florida, United States, 32611 | |
Contact: Amy Smith, MD 352-392-5633 smithaa@peds.ufl.edu | |
Contact: Emily Owens-Pickle, RN 352 392-5633 emily.owens@pedcard.ufl.edu | |
Principal Investigator: Amy Smith, MD | |
United States, Illinois | |
Children's Memorial Hospital | Recruiting |
Chicago, Illinois, United States, 60614-3394 | |
Contact: Stewart Goldman, MD 773-880-3270 SGoldman@childrensmemorial.org | |
Contact: Carrie Kempler, MPH 773-883-6186 ckempler@childrensmemorial.org | |
Principal Investigator: Stewart Goldman, MD | |
United States, Maryland | |
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Kenneth Cohen, MD 410-614-5055 kcohen@jhmi.edu | |
Contact: Tammy Scott, RN 410 614-5055 scottta@jhmi.edu | |
Principal Investigator: Kenneth J. Cohen, MD, MBA | |
United States, New York | |
NYU Medical Center, Hassenfeld Clinic | Recruiting |
New York, New York, United States, 10016 | |
Contact: Jeffrey Allen, MD 212-263-8400 jeffrey.allen@NYUMC.org | |
Contact: Erin Harnett, RN 212 263-9935 Erin.Harnett@nyumc.org | |
Principal Investigator: Jeffrey Allen, MD | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Tanya Trippet, Dr. 212-639-3295 trippet1@mskcc.org | |
Contact: Katherine Rolla 212-639-3295 rollak@mskcc.org | |
Principal Investigator: Tanya Trippet, MD | |
University of Rochester Medical Center, Strong Memorial Hospital | Recruiting |
Rochester, New York, United States, 10016 | |
Contact: David Korones, MD 585-275-2981 David_Korones@URMC.Rochester.edu | |
Contact: Lisa Jansson, RN 585 273-3778 Lisa_Jansson@urmc.Rochester.edu | |
Principal Investigator: David Korones, MD | |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232-6310 | |
Contact: John F. Kuttesch, MD, Ph.D. 615-322-0333 John.Kuttesch@Vanderbilt.Edu | |
Contact: Kathleen M VonWahlde, RN 615 322-0333 kate.vonwahlde@Vanderbilt.Edu | |
Principal Investigator: John F. Kuttesch, MD, Ph.D. | |
United States, Texas | |
The University of Texas/M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Johannes Wolff, MD 713-794-4963 jwolff@mdanderson.org | |
Contact: Margaret Nagel, RN 713 745-3131 MNagel@mdanderson.org | |
Principal Investigator: Johannes Wolff, MD | |
Canada, Alberta | |
Alberta Children's Hospital | Recruiting |
Calgary, Alberta, Canada, T3B 6A8 | |
Contact: Aru Narendran, MD 403 955-7641 anarendr@ucalgary.ca | |
Contact: Janice Hamilton, RN 403 955-7641 Janice.Hamilton@calgaryhealthregion.ca | |
Principal Investigator: Aru Narendran, MD | |
Canada, Ontario | |
The Hospital For Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Ute Bartels, MD 416 813-5249 ute.bartels@sickkids.ca | |
Contact: Janet Gammon, RN 416 813-5249 janet.gammon@sickkids.ca | |
Principal Investigator: Dr. Eric Bouffet, MD | |
Sub-Investigator: Ute Bartels, MD | |
Principal Investigator: Sylvain Baruchel, MD | |
Israel | |
The Chaim Sheba Medical Center | Recruiting |
Tel-Hashomer, Israel, 52621 | |
Contact: Michal Yalon, MD 972-544-413139 michal.yalon@sheba.health.gov.il | |
Principal Investigator: Michal Yalon, MD |
Study Director: | Leonardo Viana, MD | YM BioSciences Inc. |
Study Director: | Paul Keane, MD | YM BioSciences Inc. |
Principal Investigator: | Eric Bouffet, MD | The Hospital for Sick Children |
Principal Investigator: | Ute Bartels, MD | The Hospital for Sick Children |
Principal Investigator: | Sylvain Baruchel, MD | The Hospital for Sick Children |
Responsible Party: | YM BioSciences Inc. ( Dr. Leonardo Viana ) |
Study ID Numbers: | YMB1000-013 |
Study First Received: | January 11, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00600054 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Diffuse intrinsic pontine glioma Common Terminology Criteria Epidermal Growth factor receptor Human antihuman antibody |
pharmacokinetics monoclonal antibody Informed Consent Form |
Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Recurrence Immunoglobulins Neoplasms, Glandular and Epithelial |
Disease Attributes Neoplasms Pathologic Processes Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Pharmacologic Actions |