Testing the Safety, Tolerability and Immunological Effects of SurVaxM in Children and Young Adults with Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Brain Tumor	NCT ID:	NCT04978727
Trial Phases:	Phase I	Protocol IDs:	PBTC-060 (primary) PBTC-060 NCI-2021-07694
Eligibility:	1 - 21 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Pediatric Brain Tumor Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT04978727

Summary

This phase I trial studies the side effects of SurVaxM in treating children and young adults with brain tumors that are newly diagnosed, have come back (relapsed), or have spread to other places in the body (metastatic). SurVaxM is designed to tell the body’s immune system to look for tumor cells that express a protein called survivin and destroy them. The survivin protein can be found on up to 95% of glioblastomas and other types of cancer but is not found in normal cells. If the body’s immune system knows to destroy cells that express survivin, it may help to control tumor growth and recurrence. This trial is studying a vaccine called SurVaxM combined with Montanide ISA 51 to see if it is safe and tolerated without severe side effects in children.

Objectives

PRIMARY OBJECTIVE:
I. To assess the toxicity profile of SVN53-67/M57-KLH peptide vaccine (SurVaxM) in emulsion with incomplete Freund's adjuvant (Montanide) plus sargramostim in children with relapsed or progressive medulloblastoma and high-grade glioma (HGG), ependymoma and non-recurrent diffuse intrinsic pontine glioma (DIPG) post-radiation therapy (RT).

SECONDARY OBJECTIVES:
I. To examine the ability of quantitative magnetic resonance (MR) diffusion weighted imaging/apparent diffusion coefficient (ADC) mapping to provide early assessment of tumor behavior and specifically distinguish pseudoprogression/tumor inflammation from tumor progression.
II. To explore the use of serial MR permeability (dynamic contrast-enhanced [DCE]) and MR perfusion (dynamic susceptibility contrast [DSC]) to determine if elevated relative cerebral blood volume (rCBV) and vascular permeability (ktrans) can distinguish pseudoprogression/tumor inflammation from tumor progression in tumors treated on this protocol.

EXPLORATORY OBJECTIVES:
I. To measure survivin-specific antibody and T cell responses to SurVaxM in emulsion with Montanide ISA 51 plus sargramostim in children with relapsed or progressive medulloblastoma, high grade glioma (HGG), ependymoma and non-recurrent DIPG post RT.
II. To describe the preliminary efficacy of the proposed regimen via radiographic response rates, progression free survival (PFS) and overall survival (OS) in the context of a pilot study.
III. To evaluate humoral immune responses and human leukocyte antigen (HLA) genotype in relationship to cellular measured immune responses in pediatric patients receiving SurVaxM vaccine.
IV. To assess tumor response using Response Assessment in Pediatric Neuro-Oncology (RAPNO) published criteria for medulloblastoma, HGG, DIPG in comparison to modified Macdonald response criteria.

OUTLINE:
Patients receive SurVaxM and Montanide ISA 51 mixture subcutaneously (SC) followed by sargramostim (or biosimilar) given as a separate SC injection every 2 weeks for 6 weeks. Starting week 9, patients receive SurVaxM and Montanide ISA 51 mixture SC followed by sargramostim (or biosimilar) given SC every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo magnetic resonance imaging (MRI) and blood sample collection throughout the study.

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