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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 CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
University of Colorado Health Sciences CenterDenver, Colorado  80262
University of FloridaGainesville, Florida  32610-0277
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Seattle Children's HospitalSeattle, Washington  98105
Children's Healthcare of Atlanta at EglestonAtlanta, Georgia  30322
John Hopkins Medical CenterBaltimore, Maryland  21287
Children's Mercy Hospital & ClinicsKansas City, Missouri  64108
MD Anderson Cancer Center Orlando at Arnold Palmer Hospital for ChildrenOrlando, Florida  32806