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Modified Measles Virus (MV-NIS) for Children and Young Adults With Recurrent Medulloblastoma or Recurrent ATRT

Atypical Teratoid/Rhabdoid Tumor Clinical Trial

Official title:
A Phase 1 Study of Modified Measles Virus (MV-NIS) for the Treatment of Children and Young Adults With Recurrent Medulloblastoma or Recurrent Atypical Teratoid Rhabdoid Tumors (ATRT)

Clinical Trial Summary

This is a three arm Phase I study within the Pacific Pediatric Neuro-Oncology Consortium (PNOC). This study will look to determine the safety and recommended phase 2 dose of the modified measles virus (MV-NIS) in children and young adults with recurrent medulloblastoma or atypical teratoid rhabdoid tumor (ATRT).

Clinical Trial Description

This is an open label, multi-center, Phase I study to assess the safety of administering MV-NIS directly into the tumor bed (for locally recurrent medulloblastoma or ATRT patients) or into the subarachnoid space (for disseminated recurrent medulloblastoma or ATRT patients). For locally recurrent patients (patients in the first arm) MV-NIS will be directly administered into the tumor bed following a standard of care surgical resection. For patients with disseminated recurrence (patients in the second or third arm), MV-NIS will be injected via lumbar puncture (LP). Patients in the second arm will receive a one-time administration of MV-NIS. Patients will be closely monitored for 30 days after injection, and then followed for evaluation of 6 month progressive free survival and overall response rate. Patients in the third arm will receive two administrations of MV-NIS. Patients will be closely monitored for 56 days after injection, and then followed for evaluation of 4 month progressive free survival. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02962167
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 1
Start date February 22, 2017
Completion date May 10, 2023
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