Clareo Health | External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas
External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Children's Healthcare of Atlanta
Dana-Farber Cancer Institute
M.D. Anderson Cancer Center
Phoenix Children's Hospital
Alberta Children's Hospital
University of Colorado, Denver
Seattle Children's Hospital
Johns Hopkins University
Children's Mercy Hospital Kansas City
University of Florida
Age
3–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have either (1) histologic proof of a high-grade astrocytoma reviewed by a POETIC institutional pathologist or (2) a radiological diagnosis via MRI scan of a typical diffuse pontine tumor made by a POETIC institutional neuroradiologist. Patients with a radiological diagnosis via MRI scan of a typical diffuse pontine tumor will be enrolled on the diffuse pontine tumor arm of the study regardless of histology in cases that are biopsied. Note: For collaborating non-POETIC institutions, the reviews may be done by an institutional pathologist/neuroradiologist.
Patients must begin study prescribed therapy within 42 days of neurosurgical resection or biopsy of the tumor (high-grade astrocytoma patients) or radiological diagnosis (diffuse pontine tumor patients).
Age ≥ 3-years and \< 22-years-old.
Brain MRI (and any other studies done according to clinical indications) must not show any definitive evidence of leptomeningeal or extra-neural metastases.
ANC ≥ 1000/μL and platelet count ≥ 100,000/μL
Patients must have adequate organ function as defined by:
Hepatic: total bilirubin \< 1.5 mg/dl, AST ≤ 2.5 x the upper limit of normal.
Renal: serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.
The patient, or for minors, a parent or legal guardian, must give informed written consent indicating they are aware of the investigational nature of this study.
You may not be if
Evidence of leptomeningeal or extra-neural metastatic disease.
Prior radiation therapy or chemotherapy
Pregnancy, mothers unwilling to refrain from breast-feeding, and sexually mature patients unwilling to practice an effective form of birth control.
Other significant concomitant medical illnesses that would compromise the patient's ability to receive all prescribed study therapy.
Prior therapy which specifically and directly targets the EGFR pathway.
Prior severe infusion reaction to a monoclonal antibody.
Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
