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

Eligibility Criteria

• * • DIAGNOSIS: Patients with a histologically confirmed diagnosis of a primary CNS tumor that is progressive or recurrent defined as progression in any known residual tumor, or the appearance of one or more new lesions, or new cerebrospinal fluid (CSF) positivity for malignant cells, after having failed standard therapy. At the time of diagnosis or recurrence, all tumors must have histologic verification of one of the following:
• * Medulloblastoma
• * Glioblastoma multiforme (GBM)
• * Anaplastic astrocytoma
• * High-grade astrocytoma, NOS
• * Anaplastic oligodendroglioma
• * Anaplastic ependymoma (WHO Grade III)
• * Ependymoma (WHO Grade II)
• * Age: Patients must be ≥ 1 year of age and ≤ 21 years of age at the time of screening.
• * Screening Consent: Participant is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.
• * Potential Eligibility for Study Enrollment: Patients screened for this trial should be expected to meet the criteria for treatment.
• * • 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.
• * CONCURRENT ILLNESS:
• * Active, uncontrolled infection requiring treatment (including HIV infection)
• * Patients with spinal cord primary tumors
• * Patients with relapsed or progressive DIPG or midline glioma
• * Patients with Grade I myxopapillary ependymoma
• * Patients with WHO Grade I or II gliomas are not eligible unless tumor is located within the pons or brainstem
• * 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.
• * CONCOMITANT MEDICATIONS:
• * Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
• * Patients who are receiving any cannabidiol (CBD) or medical marijuana treatment are ineligible.
• * Patients who have received the last vaccination of a live vaccine ≤ 30 days prior to enrollment are ineligible. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and must meet timeline for live vaccine.
• * Patients who have received an inactivated virus, peptide, or mRNA vaccine within 14 days of the start of protocol therapy are ineligible.
• * Patients may not be on immunosuppressive therapy, including corticosteroids (except as defined in the corticosteroids inclusion criteria) at time of enrollment. However, patients who require intermittent use of bronchodilators, local steroid injections, or topical steroids will not be excluded from the study.
• * Patients may not be receiving concomitant chemotherapy, immunotherapy, radiotherapy, radiosurgery, interferon, allergy desensitization injections, growth factors, interleukins, or any investigational therapeutic medication at the time of enrollment.
• * INABILITY TO PARTICIPATE: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity of therapy or to adhere to drug administration plan, other study procedures, and study restrictions.
• * ALLERGY: Known allergy or hypersensitivity to Keyhole Limpet Hemocyanin (KLH), granulocyte colony-macrophage stimulating factor (sargramostim) or MRI contrast agent.
• * BLEEDING DISORDER: Patients with a known coagulopathy or bleeding diathesis or requires the use of systemic, anticoagulant medication are not eligible.
• * 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 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.