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|NCT01326104 : Vaccine Immunotherapy for Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor|
|Phase||Phase 1/Phase 2|
|Ages||Min: N/A Max: 30 Years|
- 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.
- 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
- Pregnant or need to breast feed during the study period.
- Active infection requiring treatment or an unexplained febrile (> 101.5o F) 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 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
- Patients receiving any other concurrent anticancer or investigational drug therapy.
- Patients with any clinically significant unrelated systemic illness (serious
infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
- Patients with inability to return for follow-up visits or obtain follow-up studies
required to assess toxicity to therapy.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01326104
| Link to official Clinicaltrials.gov listing