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Clinical trialNCT04978727Active, not recruitingPhase 1Interventional

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

SponsorChildren's Oncology GroupEnrollment35Anaplastic AstrocytomaAnaplastic EpendymomaAnaplastic OligodendrogliomaDiffuse Intrinsic Pontine GliomaEpendymomaGlioblastoma Multiforme+2 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Patients will receive a vaccine called SurVaxM on this study. 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. 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. SurVaxM will be mixed with Montanide ISA 51 before it is given. Montanide ISA 51 is an ingredient that helps create a stronger immune response in people, which helps the vaccine work better. This study has two phases: Priming and Maintenance. During the Priming Phase, patients will get one dose of SurVaxM combined with Montanide ISA 51 through a subcutaneous injection (a shot under the skin) at the start of the study and every 2 weeks for 6 weeks (for a total of 4 doses). At the same time that patients get the SurVaxM/Montanide ISA 51 injection, they will also get a second subcutaneous injection of a medicine called sargramostim. Sargramostim is given close to the SurVaxM//Montanide ISA 51 injection and works to stimulate the immune system to help the SurVaxM/Montanide ISA 51 work more effectively. If a patient completes the Priming Phase without severe side effects and his or her disease stays the same or improves, he or she can continue to the Maintenance Phase. During the Maintenance Phase, the patient will get a SurVaxM/Montanide ISA 51 dose along with a sargramostim dose about every 8 weeks for up to two years. After a patient finishes the study treatment, the doctor and study team will continue to follow his/her condition and watch for side effects up to 3 years following the last dose of SurVaxM/Montanide ISA 51. Patients will be seen in clinic every 3 months during the follow-up period.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Hospital for Sick Children

    Toronto, Ontario, Canada

United States
  • Children'S Hospital Los Angeles

    Los Angeles, California, United States

  • Lucile Packard Children'S Hospital at Stanford University Medical Center

    Palo Alto, California, United States

  • Children'S Hospital Colorado

    Aurora, Colorado, United States

  • Children'S National

    Washington D.C., District of Columbia, United States

  • University of Florida

    Gainesville, Florida, United States

  • Children'S Healthcare of Atlanta

    Atlanta, Georgia, United States

  • Ann and Robert H. Lurie Children'S Hospital of Chicago

    Chicago, Illinois, United States

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, United States

  • Memorial Sloan Kettering

    New York, New York, United States

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • Upmc Children'S Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, United States

  • Texas Children'S Hospital

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

SurVaxM for patients with non-relapsed DIPG post radiation-therapy ages ≥1 and ≤21 yearsSurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥1 and <10 yearsSurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 years
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Jul 2022
Primary completion
31 Dec 2027
Completion
31 Dec 2027
Last update posted
2 Jun 2026
Registered enrollment
35
Registry id
NCT04978727

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.