Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor

Korábbi kezelés

• Patients receiving concomitant immunosuppressive agents for medical condition.
• Patients who need definitive radiotherapy for treatment of recurrent MB/PNET. Focal boost radiotherapy may be delivered prior to immunotherapy if required for local control.
• Patients receiving any other concurrent anticancer or investigational drug therapy.
• 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 (> 101.5F) illness.
• Known immunosuppressive disease, human immunodeficiency virus infection, or carriers of Hepatitis B or Hepatitis C virus.
• 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).

Egyéb

• Pregnant or need to breast feed during the study period.

• Screening:
• Age ≤ 30 years of age.
• Suspected first recurrence/progression of MB/PNET since completion of definitive focal +/- craniospinal irradiation. Disease progression prior to receiving definitive focal +/- craniospinal irradiation will not disqualify patients from enrollment if they have subsequently failed definitive radiotherapy and are at first recurrence/progression at time of enrollment. Patients 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) are eligible for enrollment at first disease recurrence/progression.
  • Re-MATCH Protocol:
• Patients must have histologically confirmed recurrent MB/PNET that is a first relapse/progression after completion of definitive radiotherapy +/- craniospinal irradiation. Patients with a first relapse/progression who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (ie. Gorlin's syndrome or NF1 mutation) are eligible for enrollment.
• Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.
• Karnofsky Performance Status of ≥ 50% or Lansky Performance Score of ≥ 50.
• Absolute Neutrophil Count (ANC) ≥ 1000/µl (unsupported).
• Platelets ≥ 100,000/µl (unsupported).
• Hemoglobin > 8 g/dL (may be supported).
• Serum creatinine ≤ upper limit of institutional normal
• Bilirubin ≤ 1.5 times upper limit of normal for age.
• Serum Glutamic Oxaloacetic Transaminase (ALT) ≤ 3 times institutional upper limit of normal for age.
• Serum Glutamic Oxaloacetic Transaminase (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.
• Patient or patient guardian consent to peripheral blood stem cell (PBSC) and/or bone marrow harvest following registration if PBSC or bone marrow (CD34 count of at least 2x10\^6/kg) has not been previously stored and available for use.
• Signed informed consent according to institutional guidelines must be obtained prior to registration.