Sodium Thiosulfate for Hearing Loss in Medulloblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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. In the average-risk medulloblastoma patients, this trial tests whether the addition of sodium thiosulfate (STS) to standard of care chemotherapy and radiation therapy reduces hearing loss. Previous studies with STS have shown that it may help reduce or prevent hearing loss caused by cisplatin. In the low-risk medulloblastoma patients, the study tests whether a less intense therapy (reduced radiation) can provide the same benefits as the more intense therapy. The less intense therapy may cause fewer side effects. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. The overall goals of this study are to see if giving STS along with standard treatment (radiation therapy and chemotherapy) will reduce hearing loss in medulloblastoma patients and to compare the overall outcome of patients with medulloblastoma treated with STS to patients treated without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not have received any prior radiation therapy or chemotherapy other than surgery and/or corticosteroids.
What makes the Sodium Thiosulfate treatment for hearing loss in medulloblastoma unique?
Sodium Thiosulfate is unique because it specifically targets and reduces the risk of hearing loss caused by cisplatin, a common chemotherapy drug, by neutralizing its harmful effects and boosting the body's antioxidant defenses. This approach is novel compared to other treatments that do not specifically address hearing loss in medulloblastoma patients.12345
What data supports the effectiveness of the treatment for hearing loss in medulloblastoma?
Research shows that children with medulloblastoma treated with a combination of radiotherapy and chemotherapy, including drugs like CCNU and vincristine, have a high progression-free survival rate of 85% at 5 years. This suggests that chemotherapy plays a significant role in managing medulloblastoma, which may indirectly support the use of sodium thiosulfate in this context.45678
Who Is on the Research Team?
Ralph Salloum
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for children and young adults aged 3 to 21 with newly diagnosed medulloblastoma, a brain cancer. They must have normal kidney and liver function, no prior tumor-directed therapy except surgery/corticosteroids, and not be pregnant or breastfeeding. Participants need confirmed negative spinal fluid tests for metastasis, controlled seizures if present, and normal hearing in at least one ear.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiotherapy
Patients undergo radiation therapy 5 days per week for 6 weeks and receive vincristine intravenously once weekly on weeks 2-7
Maintenance
Patients receive a combination of lomustine, cisplatin, sodium thiosulfate, and cyclophosphamide over multiple cycles, with MRI and CSF collection throughout
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Lomustine
- Mesna
- Radiation Therapy
- Sodium Thiosulfate
- Vincristine
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator