PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma

Korábbi kezelés

• Patients receiving concomitant immunosuppressive agents for medical condition.
• Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent Grade III or IV glioma.
• Patients receiving any other investigational drug therapy.
• Patients on corticosteroids \> 0.1 mg/Kg/day (i.e. \> the maximum dose of 4 mg/day).
• Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.

Más betegség

• Active infection requiring treatment or an unexplained febrile (\> 101.5 degrees F) illness.
• Known immunosuppressive disease or human immunodeficiency virus infection.
• Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
• Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).

Laborértékek

• Pregnant or need to breast feed during the study period (Negative serum pregnancy test required).

• Patients who are 3 - 35 years old
• Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
• 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.
• Brain MRI within one month prior to enrollment.
• 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).
• Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
• 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.
• Bone Marrow:
  • ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)\*.
  • Platelets ≥ 100,000/µl (unsupported)\*.
  • Hemoglobin \> 8 g/dL (may be supported).
• Renal:
  • Serum creatinine ≤ upper limit of institutional normal.
• 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.
• 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.
• Signed informed consent according to institutional guidelines must be obtained prior to registration.
• Any prior chemoradiotherapy is allowed.