Recurrent Diffuse Pontine Gliomas Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | December 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 18 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Alberta Children's Hospital | Calgary | Alberta |
| Canada | The Hospital For Sick Children | Toronto | Ontario |
| Israel | The Chaim Sheba Medical Center | Tel-Hashomer | |
| United States | The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins | Baltimore | Maryland |
| United States | Children's Memorial Hospital | Chicago | Illinois |
| United States | Children's Hospital/University of Colorado | Denver | Colorado |
| United States | University of Florida Shands Cancer Center | Gainesville | Florida |
| United States | The University of Texas/M.D. Anderson Cancer Center | Houston | Texas |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | NYU Medical Center, Hassenfeld Clinic | New York | New York |
| United States | University of Rochester Medical Center, Strong Memorial Hospital | Rochester | New York |
| United States | Children's National Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| YM BioSciences |
United States, Canada, Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the objective response rate | To determine response rate on week 18 | No | |
| Secondary | To evaluate the safety profile of single agent nimotuzumab in this population | safety will be evaluated after each study drug administration | Yes |