MV-NIS: Modified Measles Virus for Children and Young Adults with Recurrent ATRT
Summary
The main purpose of MV-NIS is to study the effects of the safety and appropriate dose level of the modified measles virus (MV-NIS) in children and young adults with recurrent (disease has returned) medulloblastoma or ATRT. There are two arms, or groups, for this study, those with that have had their cancer return in the same area (locally recurrent) and those that have had their cancer return in other areas farther away from the original tumor (distant/disseminated recurrent). MV-NIS works by infecting cancer cells leading to the death of the cancer.
Trial Information
What to expect:
Once a patient has been confirmed to be eligible for trial enrollment, they will receive MV-NIS directly into the tumor.
Patients enrolled to this trial will only receive one injection or dose of MV-NIS
After receiving MV-NIS, patients will be followed for 24 months to monitor safety and effectiveness of the MV-NIS therapy
Approach
Treatment arms:
ARM A: Patients with local recurrent disease will undergo surgery to remove the tumor and will have MV-NIS delivered to the tumor area at the time of surgery. Patients in this group must have had a negative MRI of the spine and negative lumbar puncture within 21 days prior to trial enrollment.
ARM B: Enrollment has been completed on this arm is no longer available.
To be eligible for this trial, patients must have also had primary therapy including one of the following:
Surgery followed by high dose chemotherapy with stem cell transplant (stem cell rescue)
Surgery, radiation and chemotherapy
All patients must have recovered from all prior therapy side effects of chemotherapy, immunotherapy, or radiation prior to trial entry.
Additional Information
NCT02962167
Full Details on ClinicalTrials.Gov
This study is available at 8 hospital locations throughout the United States.
California:
Children's Hospital Los Angeles
Contact: Ashley Margol, MD 323-361-5642 amargol@chla.usc.edu
Contact: Girish Dhall, MD (323) 361-4629 gdhall@chla.usc.edu
UCSF Helen Diller Family Comprehensive Cancer Center (San Francisco)
Contact: Sabine Mueller, MD 415-476-3831 sabine.mueller@ucsf.edu
Illinois: Ann & Robert H. Lurie Children's Hospital of Chicago
Contact: Angela Waanders, MD, MPH 312-227-4873 awaanders@luriechildrens.org
Contact: Stewart Goldman, MD (312) 227-4873 sgoldman@luriechildrens.org
Missouri: Washington University in St. Louis
Contact: Karen Gauvain, MD 314-454-2002 gauvain_k@kids.wustl.edu
Contact: Josh Rubin, MD 314-286-2790 rubin_j@kids.wustl.edu
Ohio: Nationwide Children's Hospital
Contact: Mohamed AbdelBaki, MD 614-722-4087 Mohamed.AbdelBaki@NationwideChildrens.org
Contact: Johnathan Finlay, MD, MB, ChB, FRCP 614-722-4087 Jonathan.Finlay@nationwidechildrens.org
Pennsylvania: Children's Hospital of Philadelphia
Contact: Cassie Kline, MD, PhD KLINEC@EMAIL.CHOP.EDU
Contact: Kristina Cole, MD, MPH colek@email.chop.edu
Utah: University of Utah
Contact: Nicholas Whipple 801-662-4700 nicholas.whipple@hsc.utah.edu
Contact: Carol Bruggers 8001-662-4700 Carol.bruggers@imail.org
Washington: Seattle Children's Hospital
Contact: Sarah Leary, MD 206-987-2106 sarah.leary@seattlechildrens.org
Contact: Nicholas Vitanza, MD 206-987-2106 nicholas.vitanza@seattlechildrens.org
Eligibility
Inclusion Criteria
Patient’s must be 12 months-39 years of age at diagnosis
Must have documented evidence of local recurrence
Patients must have fully recovered from side effects of prior therapy including chemotherapy, immunotherapy and radiation therapy
Patients must have adequate organ function that will be confirmed through a routine blood draw
Females of childbearing age will need to have a negative pregnancy test.
Patients of childbearing or child fathering age must agree to use appropriate contraception
Exclusion Criteria
Chemotherapy or radiation therapy within 3 weeks of study enrollment
Patients receiving other investigational drugs or therapies
Prior history of allergic reaction to measles virus vaccine
Current uncontrolled infection
Medical issues that can interfere with study procedures or cause problems receiving protocol therapy (HIV positive, history of hepatitis B or C )
Any medical or psychiatric condition that, in the judgement of the study investigator makes the patient inappropriate for study enrollment.
Contact Information
Study Chair: Sabine Mueller, MD, PhD, MAS
Phone: 415-476-3831
Email: sabine.mueller@ucsf.edu
Contact: Rosemarie Dehesa
Phone: 415-502-1600
Email: rosemarie.dehesa@ucsf.edu