A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (NCT04978727)
A Pilot Study of Safety, Tolerability, and Immunological Effects of SurVaxM in Pediatric Patients With Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Los Angeles — Los Angeles, California
Age range: 1 Year to 21 Years
🧪 Interventions in This Study
- SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 years (BIOLOGICAL)
- SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥1 and <10 years (BIOLOGICAL)
- SurVaxM for patients with non-relapsed DIPG post radiation-therapy ages ≥1 and ≤21 years (BIOLOGICAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Children's Hospital Los Angeles — Los Angeles, California
- Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto, California
- Children's Hospital Colorado — Aurora, Colorado
- Children's National — Washington D.C., District of Columbia
- University of Florida — Gainesville, Florida
- Children's Healthcare of Atlanta — Atlanta, Georgia
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- Memorial Sloan Kettering — New York, New York
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- Texas Children's Hospital — Houston, Texas
- Hospital for Sick Children — Toronto, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Medulloblastoma
- Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma — Birmingham, Alabama
- A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma — Palo Alto, California
- HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors — Birmingham, Alabama
- Comparison of Neurocognitive Outcome in Two Standard Regimen for Treatment of Low-risk Medulloblastoma — Birmingham, Alabama
- Liothyronine in Combination With BIT Regimen for Medulloblastoma With or Without Minimal Residual Disease — San Francisco, California
Explore by condition: All Medulloblastoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.