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| Sponsor: | Stanford University |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) National Cancer Institute (NCI) |
| Information provided by: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01058850 |
Purpose
This is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients with the EGFRvIII peptide vaccine after conventional radiation.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Cancer Brain Stem Tumors Pontine Tumors |
Biological: Rindopepimut |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Rindopepimut After Conventional Radiation in Children With Diffuse Intrinsic Pontine Gliomas |
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
3.1.1 Patients must be at least 3 years of age and < = 18 years of age at the time of study enrollment.
3.1.2 Patients must have clinical findings and neuroradiographic findings consistent with diffuse intrinsic pontine glioma. Histologic confirmation of diagnosis is not required for diffuse intrinsic pontine gliomas. A copy of the MRI must be submitted for verification of eligibility.
3.1.3 Patients must have received conventional radiation therapy of total radiation dosage ranging from 5400 to 6000 cGy administered in daily fractions of 150 to 200 cGy over 6 weeks.
3.1.4 Treatment must start at 14 to 28 days after completion of conventional radiation
3.1.5 Patients receiving systemic corticosteroid therapy must be on a tapering or stable low (2 mg twice daily) dose of dexamethasone two weeks after conventional radiation.
Contacts and Locations| Contact: Paul Fisher, MD | (650) 497-8953 | neuroonc@lpch.org |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Paul Fisher, MD 650-721-5889 pfisher@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Sub-Investigator: Albert J Wong | |
| Principal Investigator: Paul Graham Fisher | |
| Sub-Investigator: Michelle Monje-Deisseroth MD PhD | |
| Sub-Investigator: Michael S. B. Edwards | |
| Sub-Investigator: Raphael Guzman | |
| Sub-Investigator: Gordon Li | |
| Principal Investigator: | Paul Graham Fisher | Stanford University |
More Information
| Responsible Party: | Paul Graham Fisher, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01058850 History of Changes |
| Other Study ID Numbers: | SU-01062010-4642, PEDSBRN0008, 1RC2CA148491-01 |
| Study First Received: | January 27, 2010 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
Brain Neoplasms Brain Stem Neoplasms Pontine Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Infratentorial Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
