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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the objective response rate | To determine response rate on week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety profile of single agent nimotuzumab in this population | safety will be evaluated after each study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital/University of Colorado | Denver | Colorado | 80045 | United States | ||
| Children's National Medical Center |
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|
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32611 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614-3394 | United States |
| The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| NYU Medical Center, Hassenfeld Clinic | New York | New York | 10016 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Rochester Medical Center, Strong Memorial Hospital | Rochester | New York | 10016 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-6310 | United States |
| The University of Texas/M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| The Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| The Chaim Sheba Medical Center | Tel Litwinsky | Tel-Hashomer | 52621 | Israel |
| ID | Term |
|---|---|
| D000080443 | Diffuse Intrinsic Pontine Glioma |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020295 | Brain Stem Neoplasms |
| D015192 | Infratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
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