PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma (PRiME)

This is an interventional treatment trial for Recurrent Medulloblastoma focused on measuring Glioma, Medulloblastoma, PRiME, Pro00079843, Thompson, Pediatric, Landi Read More

Inclusion Criteria:

1. Patients who are 3 - 35 years old
2. Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
3. Radiology evidence of recurrent medulloblastoma (reMB) or recurrent Grade III and IV glioma. Patients will be considered for a biopsy or resection of the recurrent/progressive tumor at the discretion of the treating neurosurgeon and neuro-oncologist.
4. Brain MRI within one month prior to enrollment.
5. Received prior therapy for their initial diagnosis prior to recurrence/progression or who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation).
6. Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
7. Karnofsky Performance Status (KPS) of ≥ 60% (KPS for > 10 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for ≤ 10 years of age) assessed within 2 weeks prior to registration. Patients who are unable to walk because of paralysis but who are up in a wheel chair will be considered ambulatory for the purposes of the performance score.

8. Bone Marrow:

   • ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)*.
   • Platelets ≥ 100,000/µl (unsupported)*.
   • Hemoglobin > 8 g/dL (may be supported).

9. Renal:

   • Serum creatinine ≤ upper limit of institutional normal.

10. Hepatic:

    • Bilirubin ≤ 1.5 times upper limit of normal for age.
    • SGPT (ALT) ≤ 3 times institutional upper limit of normal for age.
    • SGOT (AST) ≤ 3 times institutional upper limit of normal for age.
11. Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
12. Signed informed consent according to institutional guidelines must be obtained prior to registration.
13. Any prior chemoradiotherapy is allowed.

Exclusion Criteria:

1. Pregnant or need to breast feed during the study period (Negative serum pregnancy test required).
2. Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F) illness.
3. Known immunosuppressive disease or human immunodeficiency virus infection.
4. Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
5. Patients receiving concomitant immunosuppressive agents for medical condition.
6. Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent Grade III or IV glioma.
7. Patients receiving any other investigational drug therapy.
8. Patients on corticosteroids > 0.1 mg/Kg/day (i.e. > the maximum dose of 4 mg/day).
9. Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
10. Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.