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A Phase II Trial of 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 (POE08-01)


Phase 2
3 Years
21 Years
Open (Enrolling)
Both
Brain Cancer

Thank you

Trial Information

A Phase II Trial of 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 (POE08-01)


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

- Patients with known Gilbert's Syndrome.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the proportion of patients with high-grade astrocytoma and diffuse pontine tumors achieving one year progression free survival.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Ira Dunkel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

09-014

NCT ID:

NCT01012609

Start Date:

November 2009

Completion Date:

November 2014

Related Keywords:

  • Brain Cancer
  • high-grade astrocytomas
  • newly diagnosed diffuse pontine tumors
  • External beam radiation therapy
  • cetuximab
  • irinotecan
  • POETIC
  • Astrocytoma
  • Brain Neoplasms
  • Brain Stem Neoplasms

Name

Location

MD Anderson Cancer Center Houston, Texas  77030-4096
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
University of Colorado Health Sciences Center Denver, Colorado  80262
University of Florida Gainesville, Florida  32610-0277
Dana Farber Cancer Institute Boston, Massachusetts  02115
Seattle Children's Hospital Seattle, Washington  98105
Children's Healthcare of Atlanta at Egleston Atlanta, Georgia  30322
John Hopkins Medical Center Baltimore, Maryland  21287
Children's Mercy Hospital & Clinics Kansas City, Missouri  64108
MD Anderson Cancer Center Orlando at Arnold Palmer Hospital for Children Orlando, Florida  32806