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
NCT ID: NCT01012609
Last Updated: 2022-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2009-10-30
2018-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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pts with high-grade astrocytoma
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan
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.
pts with diffuse pontine tumor
This is a 2-group parallel (high-grade astrocytoma, diffuse pontine tumor), single stage study investigating cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan in pediatric and young adult patients. Optional exploratory components of the study include (1) correlation of tumor molecular markers with outcome, (2) CSF proteomics, and (3) assay of serum cytokine levels in patients who develop a cetuximab-associated rash.
cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan
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.
Interventions
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cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Patients with known Gilbert's Syndrome.
3 Years
21 Years
ALL
No
Sponsors
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Children's Healthcare of Atlanta
OTHER
Dana-Farber Cancer Institute
OTHER
M.D. Anderson Cancer Center
OTHER
Phoenix Children's Hospital
OTHER
Alberta Children's Hospital
OTHER
University of Colorado, Denver
OTHER
Seattle Children's Hospital
OTHER
Johns Hopkins University
OTHER
Children's Mercy Hospital Kansas City
OTHER
University of Florida
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ira Dunkel, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Seattle Children'S Hospital
Seattle, Washington, United States
Alberta Children'S Hospital
Calgary, Alberta, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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09-014
Identifier Type: -
Identifier Source: org_study_id
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