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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

This is a two 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 Summary:

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, MV-NIS will be directly administered into the tumor bed following a standard of care surgical resection. For patients with disseminated recurrence, MV-NIS will be injected via lumbar puncture (LP). This is a one-time administration for either locally or disseminated recurrence.

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.

Current Primary Outcome:

• Number of Participants with Adverse Events as Assessed by CTCAE v4. [ Time Frame: 12 months ]
  The safety of the modified measles virus will be assessed by monitoring for adverse events. Subjects will be monitored for adverse events via scheduled laboratory assessments, vital sign measurements, and physical examinations. The severity of any toxicity will be graded according to the NCI CTCAE v4.0. We will aggregate this information into the number of subjects with adverse events that are related to study treatment.
• Recommended Phase 2 Dose. [ Time Frame: 12 months ]
  The maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) will be the dose level at which 6 evaluable patients have been treated and at most 1 patient experienced a DLT and the next highest dose level is too toxic or we have reached the protocol defined highest dose level.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Objective Response Rate (ORR) [ Time Frame: 24 months ]
  Any eligible patient that receives MV-NIS will be considered evaluable for clinical efficacy. The objective response criteria is that partial response (PR) and complete response (CR) must be confirmed at least 8 weeks after the initial PR or CR criteria is met.
• Progression Free Survival (PFS) [ Time Frame: 24 months ]
  For patients who are still progression free at the time of analysis, PFS will be censored at the last contact date. PFS will be estimated using the Kaplan-Meier method.

Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: November 2, 2016
Date Started: November 2016
Date Completion: February 2019
Last Updated: February 6, 2017
Last Verified: February 2017