COG ACNS2031

Clinical Trial Title A Phase 3 Study of Sodium Thiosulfate for the Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy for Children with Medulloblastoma with Low-Risk Features
Trial Status Open to Enrollment
Start Date 02/20/2023
Location Randall Children's Hospital at Legacy Emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Childhood Medulloblastoma
Description This phase III trial tests two hypotheses in patients with low-risk and average-risk medulloblastoma. Medulloblastoma is a type of cancer that occurs in the back of the brain. The term, risk, refers to the chance of the cancer coming back after treatment. Subjects with low-risk medulloblastoma typically have a lower chance of the cancer coming back than subjects with average-risk medulloblastoma. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects or unintended health conditions that arise due to treatment include learning difficulties, hearing loss or other issues in performing daily activities. Standard therapy for newly diagnosed average-risk or low-risk medulloblastoma includes surgery, radiation therapy, and chemotherapy (including cisplatin). Cisplatin may cause hearing loss as a side effect.
Eligibility Criteria

Eligible Patients

  • Patients must be >= 4 years and =< 21 years of age at the time of enrollment
  • Patients must be newly diagnosed medulloblastoma and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative
  • Patients must have negative lumbar CSF cytology
  • Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =< 1.5 cm^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed
  • Patients must weigh > 10 kg
  • Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0)

 
Please contact Legacy's Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel for additional study inclusion/exclusion information.

 
IRB Number Central IRB
Notes Study Details | NCT05382338 | A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss | ClinicalTrials.gov
Principal Investigator Jason Glover, MD
Contact Name Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel
Contact Phone 503-276-9300
Contact Fax 503-276-9351
Contact E-Mail childcanc@LHS.ORG