Standard treatment for patients with diffuse pontine tumors is radiation therapy, but less than 10% of patients are cured. Adding standard chemotherapy has not improved the cure rate. Standard treatment for high-grade astrocytomas is surgery and radiation. The surgeon removes as much of the tumor as she or he can. Radiation after that tries to kill any cancer cells that are left. Some patients also get chemotherapy. These are anti-cancer drugs. They can be given during or after radiation. Current standard treatments do not cure many patients. In this study the doctors are adding a new medication called cetuximab to the treatment and will also use a chemotherapy medication (irinotecan) that has been promising for patients treated for recurrent disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
Phoenix Children'S Hospital
Phoenix, Arizona, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
MD Anderson Cancer Center Orlando at Arnold Palmer Hospital for Children
Orlando, Florida, United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
John Hopkins Medical Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Md Anderson Cancer Center
Houston, Texas, United States
...and 2 more locations
Number of Participants With High-grade Astrocytoma and Diffuse Pontine Tumors Achieving One Year Progression Free Survival.
Time frame: 1 year
Number of Participants Experiencing Toxicity
To determine the safety of cetuximab administered weekly in conjunction with involved field external beam radiation therapy for diffuse pontine tumors and high-grade astrocytomas, toxicities will be assessed via the NCI Common Terminology Criteria for Adverse Events (CTCAE, version 3.0)
Time frame: 2 years
Time to Progression
Time frame: 2 years
Number of Participants Who Have Undergone Tumor Analysis
Participant tumor analysis for potential associations between primary tumor tissue molecular markers and tumor response.
Time frame: 2 years
Number of Samples Demonstrating EGFR Copy Number Gain
Identify gene transcripts for putative cetuximab
Time frame: 2 years
Number of Participant Tumors Analyzed for Potential Association Between Histology (Grade) With Protein and ELISA Measurements of Those Proteins.
Time frame: 2 years
Percentage of Participants With Development of Rash, Either Acneiform and/or Desquamation
The purpose is to investigate whether the rash associated with cetuximab is secondary to an inflammatory pathway initiated and mediated by the action of cetuximab on host cells.
Time frame: 2 years
Event Free Survival
Time frame: up to 12 months
Overall Survival
Time frame: Up to 43 months
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