Clinical Trial
PNOC005: A phase 1 study of modified measles virus for the treatment of children and young adults with recurrent medulloblastoma or recurrent atypical teratoid rhabdoid tumors (ATRT)
Please note, this study has closed to accrual and is no longer accepting patients. Patients are stratified at time of enrollment into three groups. Group A: Patients with locally recurrent medulloblastoma or ATRT will undergo surgery to remove the recurrent tumor and the MV-NIS virus will be injected directly into the tumor bed. Group B: Patients with recurrent disseminated medulloblastoma or ATRT will receive one administration of MV-NIS via lumbar puncture into the subarachnoid space. Group C: Patients with recurrent disseminated medulloblastoma will receive two administrations of MV-NIS via lumbar puncture into the subarachnoid space.
Groups B and C are no longer recruiting.
Following MV-NIS injection, patients will be monitored for safety and toxicity and follow-up will continue for 24 months.
For children with recurrent medulloblastoma or ATRT, outcomes remains very poor. Preclinical studies have shown that treatment with modified, attenuated measles virus (MV-NIS) leads to prolonged survival in models of recurrent medulloblastoma and ATRT. Safety studies have proven that MV-NIS has an excellent safety profile and ongoing adult studies are currently testing MV NIS in adult glioblastoma, ovarian cancer, and multiple myeloma.
PRIMARY OBJECTIVES
Strata A & B: To determine the safety and recommended phase 2 dose of modified measles virus if administered into the tumor bed of patients with locally recurrent medulloblastoma or ATRT or into the subarachnoid space of patients with disseminated medulloblastoma or ATRT.
Stratum C: To determine the safety of two administrations of modified measles virus if administered into the subarachnoid space of patients with disseminated recurrent medulloblastoma.
Funding is provided by No More Kids with Cancer and Solving Kids’ Cancer.
Please note, this study has closed to accrual and is no longer accepting patients. Patients are stratified at time of enrollment into three groups. Group A: Patients with locally recurrent medulloblastoma or ATRT will undergo surgery to remove the recurrent tumor and the MV-NIS virus will be injected directly into the tumor bed. Group B: Patients with recurrent disseminated medulloblastoma or ATRT will receive one administration of MV-NIS via lumbar puncture into the subarachnoid space. Group C: Patients with recurrent disseminated medulloblastoma will receive two administrations of MV-NIS via lumbar puncture into the subarachnoid space.
Groups B and C are no longer recruiting.
Following MV-NIS injection, patients will be monitored for safety and toxicity and follow-up will continue for 24 months.
For children with recurrent medulloblastoma or ATRT, outcomes remains very poor. Preclinical studies have shown that treatment with modified, attenuated measles virus (MV-NIS) leads to prolonged survival in models of recurrent medulloblastoma and ATRT. Safety studies have proven that MV-NIS has an excellent safety profile and ongoing adult studies are currently testing MV NIS in adult glioblastoma, ovarian cancer, and multiple myeloma.
PRIMARY OBJECTIVES
Strata A & B: To determine the safety and recommended phase 2 dose of modified measles virus if administered into the tumor bed of patients with locally recurrent medulloblastoma or ATRT or into the subarachnoid space of patients with disseminated medulloblastoma or ATRT.
Stratum C: To determine the safety of two administrations of modified measles virus if administered into the subarachnoid space of patients with disseminated recurrent medulloblastoma.
Funding is provided by No More Kids with Cancer and Solving Kids’ Cancer.
Sites Offering This Trial
- CHICAGO, IL Ann & Robert H. Lurie Children’s Hospital of Chicago
- LOS ANGELES, CA Children’s Hospital Los Angeles
- COLUMBUS, OH Nationwide Children’s Hospital
- ST. LOUIS, MO St. Louis Children’s Hospital
- SEATTLE, WA Seattle Children’s Hospital
- PHILADELPHIA, PA The Children’s Hospital of Philadelphia
- San Francisco, CA UCSF Benioff Children’s Hospitals
- GAINESVILLE, FL University of Florida Shands Children’s Hospital
- SALT LAKE CITY, UT University of Utah
How to Enroll
If you believe your child or patient is eligible for this trial, contact the closest participating site or email us for more information.