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

Running, not enrolling · Phase 1

Conditions studied: Medulloblastoma, Glioblastoma Multiforme, Anaplastic Astrocytoma, High-grade Astrocytoma NOS, Anaplastic Oligodendroglioma, Anaplastic Ependymoma, Ependymoma, Diffuse Intrinsic Pontine Glioma

In brief

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.

Key facts

Study ID

NCT04978727

Run by

Children's Oncology Group

People needed

35

Starts

2022-07-01

Expected to finish

2027-12-31

Last updated by the study team

2026-06-02

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• • BREAST FEEDING WOMEN - Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SurVaxM breastfeeding should be discontinued if the mother is treated with SurVaxM. Female patients who are breastfeeding are not eligible for this study unless they agree not to breastfeed.
• Excluded Diagnoses:
• Patients with spinal cord primary tumors
• Patients with relapsed or progressive DIPG
• Patients with metastatic disseminated DIPG are not eligible. MRI of spine must be performed if disseminated disease is suspected by the treating physician.
• Patients with midline high grade gliomas including those with H3 K27M-altered diffuse midline glioma (DMG) centered outside of the pons
• Patients with Grade II myxopapillary ependymoma
• Patients with WHO Grade I or II gliomas are not eligible unless tumor is defined as DIPG as per above.
• Patients with bone-only metastatic lesions that do not have otherwise evaluable CNS disease.
• Bulky Disease
• Patients with bulky tumor on imaging are ineligible. Bulky tumor is defined as any of the following:
• Tumor with evidence of clinically significant tonsillar herniation
• Tumor with evidence of clinically significant uncal herniation causing midbrain compression or midline shift greater than 5 mm
• Tumor with a diameter >4cm in one dimension on T2/FLAIR
• Tumor that in the opinion of the site investigator, shows significantly rapid progression of mass effect in either the brain or spinal cord such that the priming phase of vaccination (i.e., 6 weeks) cannot be completed before clinical deterioration is likely to occur.
• Treating physicians should contact the Study Chair to request a rapid central imaging review to confirm fulfilment of these eligibility criteria, if they have concerns. If clinically appropriate, surgical debulking of large tumors should be considered before study entry.
• Concurrent Illness:
• Active, uncontrolled infection requiring treatment (including HIV infection)
• Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, with the exception of:
• Patients with vitiligo or resolved asthma/atopy
• Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome
• History of or ongoing pneumonitis or significant interstitial lung disease
• Patients with any clinically significant unrelated systemic illness (significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.
• Any medical condition that, in the opinion of the Principal Investigator, would compromise the patient's ability to participate in the study.

Where it is running

• 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
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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