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

January 27, 2010
October 22, 2013
June 2011
September 2013   (final data collection date for primary outcome measure)
Safety [ Time Frame: Monthly until death or until 5years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01058850 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: Monthly until death or until 5years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine Gliomas
A Phase I Study of Rindopepimut After Conventional Radiation in Children With Diffuse Intrinsic Pontine Gliomas

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain Cancer
  • Brain Stem Tumors
  • Pontine Tumors
Biological: Rindopepimut
250 or 500 mcg; intradermal injection
Other Name: CDX-110, EGFRvIII peptide vaccine
Experimental: Rindopepimut (EGFRvIII Vaccine, CDX-110)
Intervention: Biological: Rindopepimut
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
September 2013
September 2013   (final data collection date for primary outcome measure)

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.

Both
3 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01058850
PEDSBRN0008, SU-01062010-4642, 1RC2CA148491-01
Yes
Paul Graham Fisher, Stanford University
Paul Graham Fisher
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Paul Graham Fisher Stanford University
Stanford University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP