NCT02962167

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sabine Mueller, MD, PhD · Academic / Other
• Sex: All
• Age: 12 Months – 39 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Medulloblastoma, Childhood, Recurrent
• Atypical Teratoid/Rhabdoid Tumor
• Medulloblastoma Recurrent

Interventions

Type	Name	Description
BIOLOGICAL	Modified Measles Virus	Administration of MV-NIS either into the tumor bed, if surgery to remove local tumor
BIOLOGICAL	Modified Measles Virus Lumbar Puncture	Administration of MV-NIS into the cerebrospinal fluid via lumbar puncture

Timeline

• Start date: 2017-02-22
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2016-11-11
• Last updated: 2024-03-20

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study