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

Brain Cancer Clinical Trial

Official title:

A Phase I Study of Rindopepimut After Conventional Radiation in Children With Diffuse Intrinsic Pontine Gliomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01058850
• Other study ID #: PEDSBRN0008
• Secondary ID: SU-01062010-4642
• Status: Terminated
• Phase: Phase 1
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Brain Stem Neoplasms
• Brain Stem Tumors
• Diffuse Intrinsic Pontine Glioma
• Pontine Tumors

Intervention

Biological:
• Rindopepimut
250 or 500 mcg; intradermal injection

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Paul Graham Fisher	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		Monthly until death or until 5years
Secondary	Overall survival		Monthly until death or until 5years