Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children (NCT03043391) | Clinical Trial Compass
CompletedPhase 1
Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children
United States8 participantsStarted 2017-11-07
Plain-language summary
The purpose of the study is to confirm the safety of the selected dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III or IV malignant glioma, but evidence for efficacy will also be sought. The primary objective is to confirm the safety of the selected dose of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED) in children with recurrent WHO Grade III malignant glioma (anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma) or WHO Grade IV malignant glioma (glioblastoma, gliosarcoma). A secondary objective is to estimate overall survival (OS) in this population.
Who can participate
Age range12 Years ā 21 Years
SexALL
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Inclusion criteria
ā. Platelet count ā„ 125,000 per microliter prior to biopsy. Platelets ā„ 100,000 per microliter prior to infusion;
ā. Prothrombin and Activated Partial Thromboplastin Times ā¤ 1.2 x upper limit of normal (ULN) prior to biopsy;
ā. Positive serum anti-poliovirus titer ā„ 1:8 prior to biopsy;
ā. Creatinine ā¤ 1.2 x ULN prior to biopsy;
ā. Total bilirubin, AST, ALT, alkaline phosphatase ā¤ 2.5 x ULN prior to biopsy;
ā. Neutrophil count ā„ 1000 per microliter prior to biopsy;
ā. Hemoglobin ā„ 9 gm/dl prior to biopsy (can be transfused).
Exclusion criteria
ā. Patients who are less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 consecutive scans with disease progression or histopathologic confirmation of recurrent tumor.
ā. Patients who have received chemotherapy or bevacizumab ā¤ 4 weeks \[except for nitrosourea (6 weeks) or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\] prior to starting the study drug unless patients have recovered from side effects of such therapy.
What they're measuring
1
Percentage of Participants With Unacceptable Toxicity
Timeframe: 14 days after treatment with PVSRIPO
2
Percentage of Participants Requiring Low-dose Bevacizumab or Steroid
ā. Patients who have received immunotherapy ā¤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy.