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

NCT ID: NCT01058850

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rindopepimut (EGFRvIII Vaccine, CDX-110)

Group Type: EXPERIMENTAL

Rindopepimut

Intervention Type: BIOLOGICAL

250 or 500 mcg; intradermal injection

Interventions

Rindopepimut

250 or 500 mcg; intradermal injection

Intervention Type: BIOLOGICAL

Other Intervention Names

CDX-110, EGFRvIII peptide vaccine

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Paul Graham Fisher

OTHER

Sponsor Role: lead

Responsible Party

Paul Graham Fisher

Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul Graham Fisher

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-01062010-4642

Identifier Type: OTHER

Identifier Source: secondary_id

1RC2CA148491-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PEDSBRN0008

Identifier Type: -

Identifier Source: org_study_id