Status:
ACTIVE_NOT_RECRUITING
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Lead Sponsor:
Daniel Landi
Collaborating Sponsors:
Pediatric Brain Tumor Foundation
Annias Immunotherapeutics, Inc.
Conditions:
Recurrent Medulloblastoma
Recurrent Brain Tumor, Childhood
Eligibility:
All Genders
3-35 years
Phase:
PHASE1
Brief Summary
The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medullobla...
Detailed Description
Once a patient has enrolled onto this study, prior therapy will be terminated and patients will receive temozolomide 200 mg/m2/day x 5 days. If they are receiving bevacizumab at the time of enrollment...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pregnant or need to breast feed during the study period (Negative serum pregnancy test 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, myocardial infarction, myocarditis), or pulmonary disease.
- 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 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.
Key Trial Info
Start Date :
June 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03299309
Start Date
June 29 2018
End Date
April 1 2026
Last Update
July 9 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710