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Title
Status

 

PBTC-060 - A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

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PBTC-060 - A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

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DiagnosisMedulloblastoma, Glioblastoma, Anaplastic Astrocytoma, Oligodendroglioma, Ependymoma, Diffuse Intrinsic Pontine GliomaStudy StatusOpen
PhaseI
Age1 Year to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: SurVaxM (injection) 500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg.
Last Posted Update2023-11-13
ClinicalTrials.gov #NCT04978727
International Sponsor
Pediatric Brain Tumor Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Patients on this study will receive 4 doses of a vaccine called SurVaxM. While vaccines are usually thought of as ways to prevent diseases, vaccines can also be used to treat cancer. SurVaxM is designed to tell the body's immune system to look for tumor cells that express a protein called survivin and destroy them. If the body's immune system knows to destroy cells that express survivin, it may help to control tumor growth and recurrence.

 

Inclusion Criteria
  • Participant must have one of the following tumors that has progressed or come back: 
    • Medulloblastoma
    • Glioblastoma multiforme 
    • Anaplastic astrocytoma
    • High-grade astrocytoma, NOS
    • Anaplastic oligodendroglioma
    • Anaplastic ependymoma
    • Ependymoma 
    • Diffuse Intrinsic Pontine Gliomas (DIPG)
  • Participant must be ≥ 1 year of age and ≤ 21 years of age at the time of screening.
  • Participant or parent/guardian must be willing to sign a consent form and complete the study related assessments.
  • Participants must have recovered from all previous cancer therapies. 
  • Must be up and about for around 60% of the patient's waking hours
  • Participants must meet all the blood work requirements 
  • You cannot be pregnant or become pregnant on this study. If you are able to have children, you must use an acceptable form of birth control. Abstinence is included. 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.