Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine Gliomas

This study has been terminated.
(Resources can be better spent on higher enrolling studies)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Paul Graham Fisher, Stanford University
ClinicalTrials.gov Identifier:
NCT01058850
First received: January 27, 2010
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

This is a research study of patients with diffuse intrinsic pontine gliomas. We hope to learn about the safety and efficacy of treating pediatric diffuse intrinsic pontine glioma patients with the EGFRvIII peptide vaccine after conventional radiation.


Condition Intervention Phase
Brain Cancer
Brain Stem Tumors
Pontine Tumors
Biological: Rindopepimut
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Rindopepimut After Conventional Radiation in Children With Diffuse Intrinsic Pontine Gliomas

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Safety [ Time Frame: Monthly until death or until 5years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Monthly until death or until 5years ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rindopepimut (EGFRvIII Vaccine, CDX-110) Biological: Rindopepimut
250 or 500 mcg; intradermal injection
Other Name: CDX-110, EGFRvIII peptide vaccine

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

3.1.1 Patients must be at least 3 years of age and ≤ 18 years of age at the time of study enrollment.

3.1.2 Patients must 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.

3.1.3 Patients must have received conventional radiation therapy of total radiation dosage ranging from 5400 to 6000 cGy administered in fractions of 150 to 200 cGy over 6 weeks.

3.1.4 Treatment must start 14 to 28 days after completion of conventional radiation

3.1.5 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.

3.1.6 Patients life expectancy must be greater or equal to 8 weeks.

3.1.7 Patients must have a performance status (Lansky or Karnofsky) ≥ 50.

3.1.8 Platelet count ≥ 100,000/ mm3.

3.1.9 Hemoglobin ≥ 10 g/dL.

3.1.10 Creatinine ≤ 2.0 mg/dL.

3.1.11 Serum bilirubin ≤ 5.0 mg/dL.

3.1.12 If female, patients of childbearing potential must have a negative serum β-hCG pregnancy test.

3.1.13 Both male and female patients must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.

3.1.14 The patient and/or their guardian must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

3.2.1 Prior therapy for diffuse intrinsic pontine glioma, aside from surgery, conventional radiation, and temozolomide.

3.2.2 Use of any experimental drug for any reason within the 60 days prior to treatment.

3.2.3 Active infection requiring treatment.

3.2.4 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.

3.2.5 Known allergy or hypersensitivity to any of the components of the vaccine treatment, including GM-CSF, yeast derived products, or a history of anaphylactic reactions to shellfish proteins.

3.2.6 Pregnant women and women who are breast-feeding.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058850

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Paul Graham Fisher
Investigators
Principal Investigator: Paul Graham Fisher Stanford University
  More Information

No publications provided

Responsible Party: Paul Graham Fisher, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01058850     History of Changes
Other Study ID Numbers: PEDSBRN0008, SU-01062010-4642, 1RC2CA148491-01
Study First Received: January 27, 2010
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Brain Stem Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Infratentorial Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014