MV-NIS

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

STUDY AT A GLANCE

 

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:

  1. Surgery followed by high dose chemotherapy with stem cell transplant (stem cell rescue)

  2. Surgery, radiation and chemotherapy

  3. All patients must have recovered from all prior therapy side effects of chemotherapy, immunotherapy, or radiation prior to trial entry.

 

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.

ADDITIONAL INFORMATION

Full Details on ClinicalTrials.Gov

This study is available at 10 hospital locations

throughout the United States.

CONTACT INFORMATION

Study Chair: Sabine Mueller, MD, PhD, MAS

Phone: 415-476-3831

Email: sabine.mueller@ucsf.edu

Trial Coordinator: Lajhem Cambridge, MS

Phone: 415-502-1600

Email: lajhem.cambridge@ucsf.edu

Hope4ATRT Foundation

is a research entity of

Out of Zion, Inc.

Mailing Address: 

P.O. Box 6130   New York, NY  10150