January 11, 2008 |
February 5, 2009 |
October 2007 |
To determine the objective response rate [ Time Frame: To determine response rate on week 18 ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00600054 on ClinicalTrials.gov Archive Site |
To evaluate the safety profile of single agent nimotuzumab in this population [ Time Frame: safety will be evaluated after each study drug administration ] [ Designated as safety issue: Yes ] |
Same as current |
|
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma |
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. |
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Phase II |
Interventional |
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Recurrent Diffuse Pontine Gliomas |
Biological: nimotuzumab (anti EGFR humanized monoclonal antibody) |
|
|
|
Recruiting |
40 |
December 2009 |
December 2009 (final data collection date for primary outcome measure) |
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
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Both |
3 Years to 18 Years |
No |
|
United States, Canada, Israel |
|
|
NCT00600054 |
Dr. Leonardo Viana, YM BioSciences Inc. |
|
YM BioSciences |
|
Study Director: |
Leonardo Viana, MD |
YM BioSciences Inc. |
|
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 |
|
|
YM BioSciences |
February 2009 |