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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 1, 2022

Primary Completion Date

April 30, 2027

Study Completion Date

February 28, 2030

Conditions
MedulloblastomaGlioblastoma MultiformeAnaplastic AstrocytomaHigh-grade Astrocytoma NOSAnaplastic OligodendrogliomaAnaplastic EpendymomaEpendymomaDiffuse Intrinsic Pontine Glioma
Interventions
BIOLOGICAL

SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 years

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.

BIOLOGICAL

SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥1 and <10 years

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.

BIOLOGICAL

SurVaxM for patients with non-relapsed DIPG post radiation-therapy ages ≥1 and ≤21 years

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.

Trial Locations (14)

10065

Memorial Sloan Kettering, New York

14263

Roswell Park Comprehensive Cancer Center, Buffalo

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

20010

Children's National, Washington D.C.

30322

Children's Healthcare of Atlanta, Atlanta

32608

University of Florida, Gainsville

43205

Nationwide Children's Hospital, Columbus

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60611

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

90026

Children's Hospital Los Angeles, Los Angeles

94304

Lucile Packard Children's Hospital at Stanford University Medical Center, Palo Alto

M5G 1X8

Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

Roswell Park Cancer Institute

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

American Lebanese Syrian Associated Charities

OTHER

lead

Pediatric Brain Tumor Consortium

NETWORK