Phase
Condition
Brain Cancer
Neurofibromatosis
Gliomas
Treatment
PEP-CMV
Clinical Study ID
Ages 3-35 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who are 3 - 35 years old
Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IVglioma.
Radiology evidence of recurrent medulloblastoma (reMB) or recurrent Grade III and IVglioma. Patients will be considered for a biopsy or resection of therecurrent/progressive tumor at the discretion of the treating neurosurgeon andneuro-oncologist.
Brain MRI within one month prior to enrollment.
Received prior therapy for their initial diagnosis prior to recurrence/progressionor who are unable to receive radiation therapy due to genetic disorders that putthem at significant risk for radiation-induced secondary malignancies (i.e. Gorlin'ssyndrome or NF1 mutation).
Patients with neurological deficits should have deficits that are stable for aminimum of 2 weeks prior to registration.
Karnofsky Performance Status (KPS) of ≥ 60% (KPS for > 10 years of age) or Lanskyperformance Score (LPS) of ≥ 60 (LPS for ≤ 10 years of age) assessed within 2 weeksprior to registration. Patients who are unable to walk because of paralysis but whoare up in a wheel chair will be considered ambulatory for the purposes of theperformance 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 amedically acceptable form of birth control, which includes abstinence, while beingtreated on this study.
Signed informed consent according to institutional guidelines must be obtained priorto registration.
Any prior chemoradiotherapy is allowed.
Exclusion
Exclusion Criteria:
Pregnant or need to breast feed during the study period (Negative serum pregnancytest required).
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, myocardialinfarction, myocarditis), or pulmonary disease.
Patients receiving concomitant immunosuppressive agents for medical condition.
Patients who need definitive radiotherapy for treatment of recurrent MB or recurrentGrade 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 any clinically significant unrelated systemic illness (seriousinfections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
Patients with inability to return for follow-up visits or obtain follow-up studiesrequired to assess toxicity to therapy.
Study Design
Study Description
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available

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