Clinical trial NCT00600054: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: YM BioSciences
Sponsor class: INDUSTRY
First posted: 2008-01-24
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To determine the objective response rate
timeFrame: To determine response rate on week 18
Secondary outcomes:
measure: To evaluate the safety profile of single agent nimotuzumab in this population
timeFrame: safety will be evaluated after each study drug administration
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital/University of Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins
state: Maryland
city: New York
country: United States
facility: NYU Medical Center, Hassenfeld Clinic
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center, Strong Memorial Hospital
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas/M.D. Anderson Cancer Center
state: Texas
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Toronto
country: Canada
facility: The Hospital For Sick Children
state: Ontario
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
Study officials:
affiliation: The Hospital for Sick Children
name: Eric Bouffet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Ute Bartels, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Sylvain Baruchel, MD
role: PRINCIPAL_INVESTIGATOR
References: