Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma

July 4, 2011 updated by: YM BioSciences

Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the objective response rate
Time Frame: To determine response rate on week 18
To determine response rate on week 18

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety profile of single agent nimotuzumab in this population
Time Frame: safety will be evaluated after each study drug administration
safety will be evaluated after each study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YM BioSciences

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

July 6, 2011

Last Update Submitted That Met QC Criteria

July 4, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YMB1000-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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