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

Primary Purpose

Recurrent Diffuse Pontine Gliomas

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nimotuzumab (anti EGFR humanized monoclonal antibody)
Sponsored by
YM BioSciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Diffuse Pontine Gliomas focused on measuring Diffuse intrinsic pontine glioma, Common Terminology Criteria, Epidermal Growth factor receptor, Human antihuman antibody, pharmacokinetics, monoclonal antibody, Informed Consent Form

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital/University of Colorado
  • Children's National Medical Center
  • University of Florida Shands Cancer Center
  • Children's Memorial Hospital
  • The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
  • NYU Medical Center, Hassenfeld Clinic
  • Memorial Sloan-Kettering Cancer Center
  • University of Rochester Medical Center, Strong Memorial Hospital
  • Vanderbilt University Medical Center
  • The University of Texas/M.D. Anderson Cancer Center
  • Alberta Children's Hospital
  • The Hospital For Sick Children
  • The Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Outcomes

Primary Outcome Measures

To determine the objective response rate

Secondary Outcome Measures

To evaluate the safety profile of single agent nimotuzumab in this population

Full Information

First Posted
January 11, 2008
Last Updated
July 4, 2011
Sponsor
YM BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT00600054
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
YM BioSciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Diffuse Pontine Gliomas
Keywords
Diffuse intrinsic pontine glioma, Common Terminology Criteria, Epidermal Growth factor receptor, Human antihuman antibody, pharmacokinetics, monoclonal antibody, Informed Consent Form

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
nimotuzumab (anti EGFR humanized monoclonal antibody)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the objective response rate
Time Frame
To determine response rate on week 18
Secondary Outcome Measure Information:
Title
To evaluate the safety profile of single agent nimotuzumab in this population
Time Frame
safety will be evaluated after each study drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bouffet, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ute Bartels, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvain Baruchel, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital/University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614-3394
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
NYU Medical Center, Hassenfeld Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center, Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6310
Country
United States
Facility Name
The University of Texas/M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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

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