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

NCT01058850 | Terminated Phase 1 DMC

• 3 other identifiers: PEDSBRN0008SU-01062010-46421RC2CA148491-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer; Brain Stem Tumors; Pontine Tumors

Outcome Measures

Primary Outcomes (1)

• Safety

  Monthly until death or until 5years

Secondary Outcomes (1)

• Overall survival

  Monthly until death or until 5years

Study Arms (1)

Rindopepimut (EGFRvIII Vaccine, CDX-110)

EXPERIMENTAL

Biological: Rindopepimut

Interventions

Rindopepimut BIOLOGICAL

250 or 500 mcg; intradermal injection

Also known as: CDX-110, EGFRvIII peptide vaccine

Rindopepimut (EGFRvIII Vaccine, CDX-110)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must be at least 3 years of age and ≤ 18 years of age at the time of study enrollment.
• 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.
• 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.
• Treatment must start 14 to 28 days after completion of conventional radiation
• 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.
• Patients life expectancy must be greater or equal to 8 weeks.
• Patients must have a performance status (Lansky or Karnofsky) ≥ 50.
• Platelet count ≥ 100,000/ mm3.
• Hemoglobin ≥ 10 g/dL.
• Creatinine ≤ 2.0 mg/dL.
• Serum bilirubin ≤ 5.0 mg/dL.
• If female, patients of childbearing potential must have a negative serum β-hCG pregnancy test.
• Both male and female patients must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.
• The patient and/or their guardian must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Prior therapy for diffuse intrinsic pontine glioma, aside from surgery, conventional radiation, and temozolomide.
• Use of any experimental drug for any reason within the 60 days prior to treatment.
• Active infection requiring treatment.
• 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.
• 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.
• Pregnant women and women who are breast-feeding.

Sponsors & Collaborators

• Paul Graham Fisher: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Brain Stem Neoplasms

Interventions

rindopepimut

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infratentorial Neoplasms

Study Officials

• Paul Graham Fisher

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 29, 2010
• Study Start: June 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

US (1)