CompletedPhase 1

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

United States34 participantsStarted 2017-02-22

Plain-language 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).

Who can participate

Age range12 Months – 39 Years

SexALL

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Inclusion criteria

✓. \- 2 years 0.6 0.6
✓. to \<6 years 0.8 0.8

Exclusion criteria

✕Patients who have had chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy within 2 weeks prior to entering the study for local palliative XRT (small port) and within 12 weeks prior for patients that received craniospinal XRT
✕Patients who are receiving any other investigational agents
✕Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
✕Female patients of childbearing potential must not be pregnant or breast-feeding.
✕Female patients of childbearing potential must have a negative serum or urine pregnancy test (within 7 days prior to study registration)
✕Patients with known HIV positivity

What they're measuring

Number of Participants with Adverse Events as Assessed by CTCAE v5.

Timeframe: 12 months

Recommended Phase 2 Dose.

Timeframe: 12 months

Trial details

NCT IDNCT02962167

SponsorSabine Mueller, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-10

View on ClinicalTrials.gov More Medulloblastoma, Childhood, Recurrent trials