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Sodium Thiosulfate for Hearing Loss in Medulloblastoma
Study Summary
This trialtests adding a drug to standard treatment for a type of brain cancer to reduce side effects, like hearing loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't had radiation or chemotherapy, only surgery or steroids.I am not pregnant, breastfeeding, and if of childbearing potential, I agree to use effective contraception during the study.My cancer has not spread to my spine or brain, as confirmed by MRI or spinal fluid tests.My platelet count is at least 100,000 without needing a transfusion.My hemoglobin level is at least 8.0 g/dL.I am between 3 and 21 years old.My doctors suspect I have a new case of medulloblastoma.I weigh more than 10 kilograms.My recent kidney function test results are within the normal range for my age and gender.I will start the trial treatment within 31 days after my surgery.My brain functions meet the study's requirements.My hearing is within the normal range.My bilirubin levels are within the normal range for my age.I cannot have a lumbar puncture due to my condition.My surgery samples will be sent quickly, ideally within 5 days after surgery.I can have a second surgery to remove remaining tumor within a month of the first to join the study.
- Group 1: Treatment (chemoradiotherapy, maintenance)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experiment accept participants of legal age?
"Patients that fall between the ages of 3 to 21 years old are eligible for this trial."
What qualifications are needed to participate in this medical experiment?
"In order to be considered for this trial, the patient must have suffered auditory impairment due to a pharmaceutical drug and fall between 3-21 years of age. A total of 225 participants are required before completion."
Has the FDA sanctioned chemoradiotherapy and maintenance as viable treatments?
"Treatment (chemoradiotherapy, maintenance) received a score of 3 on our safety scale because the Phase 3 trial has gathered evidence in its favour and multiple rounds of data have indicated that the intervention is safe."
What is the maximum quota for enrollees of this trial?
"Affirmative, information available on clinicaltrials.gov affirms that recruitment is ongoing for this medical investigation. It was first announced on December 9th 2022 and most recently updated January 18th 2023. The trial requires the participation of 225 patients from a single location."
Is the opportunity to participate in this trial still available?
"Yes, the details on clinicaltrials.gov demonstrate that this medical trial is currently enrolling individuals. It was first introduced to the public on December 9th 2022 and has been updated as recently as January 18th 2023. The study aims to recruit 225 subjects from a single site."
What is the primary goal of this experimental research endeavor?
"The primary outcome of this trial, which will be evaluated over the course of four weeks after first dose of CDDP is Event-free Survival (EFS). Secondary objectives encompass gauging the incidence rate of cisplatin-related nephrotoxicity in both average and low risk cohorts, quantifying median summary statistics including median and range by cohort group, identifying full scale intelligence neurocognitive outcomes as well as longitudinal trajectories for patients with average-risk medulloblastoma compared to a control cohort from ACNS0331 using Wechsler Intelligence Scale Vocabulary and Block Design subtest. Lastly, estimated EFS distributions for"
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