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

Phase 2
3 Years
18 Years
Not Enrolling
Recurrent Diffuse Pontine Gliomas

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate

Outcome Time Frame:

To determine response rate on week 18

Safety Issue:


Principal Investigator

Eric Bouffet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital for Sick Children


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

December 2010

Related Keywords:

  • Recurrent Diffuse Pontine Gliomas
  • Diffuse intrinsic pontine glioma
  • Common Terminology Criteria
  • Epidermal Growth factor receptor
  • Human antihuman antibody
  • pharmacokinetics
  • monoclonal antibody
  • Informed Consent Form
  • Glioma
  • Pontine Glioma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Children's National Medical Center Washington, District of Columbia  20010-2970
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Children's Memorial Hospital Chicago, Illinois  60614
Children's Hospital/University of Colorado Denver, Colorado  80045
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Baltimore, Maryland  21287
NYU Medical Center, Hassenfeld Clinic New York, New York  10016
University of Rochester Medical Center, Strong Memorial Hospital Rochester, New York  10016
The University of Texas/M.D. Anderson Cancer Center Houston, Texas  77030