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

NCT00600054 | Completed Phase 2 DMC

• 1 other identifier: YMB1000-013
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 13

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• To determine the objective response rate

  To determine response rate on week 18

Secondary Outcomes (1)

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

  safety will be evaluated after each study drug administration

Study Arms (1)

Single arm

EXPERIMENTAL

Biological: nimotuzumab (anti EGFR humanized monoclonal antibody)

Interventions

nimotuzumab (anti EGFR humanized monoclonal antibody) BIOLOGICAL

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.

Single arm

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• YM BioSciences: lead

Study Sites (13)

Children's Hospital/University of Colorado

Denver, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32611, United States

Location

Children's Memorial Hospital

Chicago, Illinois, 60614-3394, United States

Location

The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

NYU Medical Center, Hassenfeld Clinic

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester Medical Center, Strong Memorial Hospital

Rochester, New York, 10016, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-6310, United States

Location

The University of Texas/M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

The Hospital For Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

The Chaim Sheba Medical Center

Tel Litwinsky, Tel-Hashomer, 52621, Israel

Location

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

CA (2); IL (1); US (10)