Clinical Trial Details
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NCT03299309 : PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
PhasePhase 1
AgesMin: 3 Years Max: 17 Years
Inclusion Criteria:

1. Age requirements:

1. 3-17 years old for patients with recurrent WHO grade III/IV glioma

2. 3-35 years old for patients with recurrent medulloblastoma

2. Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV

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

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 must be CMV seropositive.

7. Patients with neurological deficits should have deficits that are stable for a minimum
of 2 weeks prior to registration.

8. 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.

9. Bone Marrow:

- ANC (Absolute neutrophil count) = 1000/µl (unsupported)*.

- Platelets = 100,000/µl (unsupported)*.

- Hemoglobin > 8 g/dL (may be supported).

10. Renal:

• Serum creatinine = upper limit of institutional normal.

11. 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.

12. 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.

13. Signed informed consent according to institutional guidelines must be obtained prior
to registration.

14. Any prior chemoradiotherapy is allowed.

Exclusion Criteria:

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

2. Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F)

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.

11. Known allergy or hypersensitivity to Keyhole Limpet Hemocyanin (KLH), Granulocyte
Macrophage Colony Stimulating Factor (GM-CSF) or yeast derived products, or a history
of anaphylactic reactions to shellfish proteins.
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