Medpedia

• Brain Cancer
• Brain (Nervous System) Cancers
• Brain (Nervous System) Cancers Glioblastoma
• Brain (Nervous System) Cancers Meningioma
• Brain (Nervous System) Cancers Oligodendroglioma
• Brain (Nervous System) Cancers Astrocytoma
• Brain (Nervous System) Cancers Metastatic Spine Cancer
• Brain (Nervous System) Cancers Metastatic Brain Tumors

Inclusion Criteria:1. Children with Diffuse Intrinsic Pontine Gliomas: Patients must be 18
years of age or less and have clinical findings and neuroradiographic findings consistent
with diffuse intrinsic pontine glioma. Histologic confirmation of diagnosis is not
required for diffuse intrinsic pontine gliomas. A copy of the MRI must be submitted for
verification of eligibility.
2. Patients must have received conventional radiation therapy of total radiation dosage
ranging from 5400 to 6000 cGy administered in daily fractions of 150 to 200 cGy over 6
weeks.
3. Treatment must start at least 14 to 28 days after completion of conventional radiation.
4. Patients receiving systemic corticosteroid therapy must be on a tapering or stable low
(2 mg twice daily) dose of dexamethasone two weeks after conventional radiation.
5. Patients life expectancy must be greater or equal to 8 weeks.
6. Patients must have a performance status (Lansky or Karnofsky) >= 50.
7. If female, patients of childbearing potential must have a negative serum beta-hCG
pregnancy test and must agree to use hormonal or barrier birth control with spermicidal
gel to avoid pregnancy during the study.
8. The patient and/or their guardian must have the ability to understand and the
willingness to sign a written informed consent document.
Exclusion Criteria:1. Prior therapy for diffuse intrinsic pontine glioma (surgery and
conventional radiation are allowed).
2. Use of any experimental drug for any reason within the 60 days prior to treatment.
3. Active infection requiring treatment.
4. Known medical condition that, in the opinion of the Investigator, would compromise the
patient's ability to participate in the study. This would include chronic active hepatitis
infection, known immunosuppressive disease or concurrent neurodegenerative disease).
5. Known allergy or hypersensitivity to any of the components of the vaccine treatment,
including KLH, GM-CSF or yeast derived products.
6. Pregnant women and women who are breast-feeding.

• Biological: EGFRvIII

• Safety
  Monthly until death or until 5years
  Safety Issue: Yes
• Overall survival
  Monthly until death or until 5years
  Safety Issue: Yes

• Paul Graham Fisher
  Principal Investigator, Stanford University

• Stanford University School of Medicine
  Stanford, California, 94305, United States
  Recruiting

• Stanford University
  Lead Sponsor
• United States: Food and Drug Administration
• United States: Institutional Review Board