Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma - Full Text View

Sponsor:	YM BioSciences
Information provided by:	YM BioSciences
ClinicalTrials.gov Identifier:	NCT00600054

Purpose

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:	Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma

Resource links provided by NLM:

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by YM BioSciences:

Primary Outcome Measures:

To determine the objective response rate [ Time Frame: To determine response rate on week 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety profile of single agent nimotuzumab in this population [ Time Frame: safety will be evaluated after each study drug administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	44
Study Start Date:	October 2007
Estimated Study Completion Date:	July 2010
Primary Completion Date:	March 2010 (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. 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

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed written informed consent
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:

A history of prior use of EGFR-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors)
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600054

Locations

United States, Colorado
Children's Hospital/University of Colorado
Denver, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32611
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614-3394
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, New York
NYU Medical Center, Hassenfeld Clinic
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
University of Rochester Medical Center, Strong Memorial Hospital
Rochester, New York, United States, 10016
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6310
United States, Texas
The University of Texas/M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, Ontario
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Israel
The Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621

Sponsors and Collaborators

YM BioSciences

Investigators

Study Director:	Leonardo Viana, 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

More Information

No publications provided

Responsible Party:	YM BioSciences Inc. ( Dr. Leonardo Viana )
ClinicalTrials.gov Identifier:	NCT00600054 History of Changes
Other Study ID Numbers:	YMB1000-013
Study First Received:	January 11, 2008
Last Updated:	May 10, 2010
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by YM BioSciences:

Diffuse intrinsic pontine glioma
Common Terminology Criteria
Epidermal Growth factor receptor
Human antihuman antibody

pharmacokinetics
monoclonal antibody
Informed Consent Form

Additional relevant MeSH terms:

Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 07, 2010