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Alkylating agents

Sodium Thiosulfate for Hearing Loss in Medulloblastoma

Phase 3
Waitlist Available
Led By Ralph Salloum
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be greater than or equal to 3 years and less than 22 years of age at the time of enrollment on Step 0
Patients must weigh > 10 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trialtests adding a drug to standard treatment for a type of brain cancer to reduce side effects, like hearing loss.

Who is the study for?
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.Check my eligibility
What is being tested?
The study examines whether sodium thiosulfate can reduce cisplatin-induced hearing loss in patients with average-risk medulloblastoma during standard treatment including surgery, chemotherapy (cisplatin), and radiation. It also explores less intense therapy's effectiveness for low-risk patients to minimize side effects.See study design
What are the potential side effects?
Possible side effects include hearing loss from cisplatin; nausea, hair loss from chemotherapy; skin irritation from radiation; allergic reactions to sodium thiosulfate or other drugs used like mesna.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 3 and 21 years old.
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I weigh more than 10 kilograms.
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I will start the trial treatment within 31 days after my surgery.
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My bilirubin levels are within the normal range for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival (EFS)
Percentage of patients with >= grade 2 hearing loss
Secondary outcome measures
EFS in patients with low-risk features treated using a reduced craniospinal radiation approach
Medulloblastoma
Household material hardship as a social determinant of neurocognitive, quality of life, and psychosocial outcomes in patients with average-risk and low-risk medulloblastoma
+6 more
Other outcome measures
Attention, processing speed, memory, and executive function neurocognitive outcomes and trajectories of patients with average-risk medulloblastoma treated with STS
Blood and cerebrospinal fluid banking for future studies
HEAR-QL of patients with low-risk features treated using a reduced craniospinal radiation approach
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemoradiotherapy, maintenance)Experimental Treatment9 Interventions
CHEMORADIOTHERAPY: Patients undergo radiation therapy on weeks 1-7 and receive vincristine IV once weekly on weeks 2-7 in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning 4 weeks after chemoradiotherapy, patients receive lomustine PO on day 1 of cycles 1, 2, 4, 5, 7, and 8, cisplatin IV over 6 hours on day 1 of cycles 1, 2, 4, 5, 7, and 8, sodium thiosulfate IV over 15 minutes on day 1 of cycles 1, 2, 4, 5, 7, and 8, cyclophosphamide IV over 30-60 minutes on days 1 and 2 of cycles 3, 6, and 9, and mesna IV over 15-30 minutes TID on days 1 and 2 of cycles 3, 6, and 9. Patients also receive vincristine IV on days 1, 8, and 15 of cycles 1, 2, 4, 5, 7, and 8, and on days 1 and 8 of cycles 3, 6, and 9. Treatment repeats every 6 weeks (cycles 1, 2, 4, 5, 7 and 8) or every 4 weeks (cycles 3, 6, and 9) for up to 9 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Lomustine
2008
Completed Phase 3
~1540
Mesna
2003
Completed Phase 2
~1380
Cisplatin
2013
Completed Phase 3
~1940
Radiation Therapy
2017
Completed Phase 3
~7250
Thiosulfuric acid
FDA approved
Vincristine
2003
Completed Phase 4
~2910

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,175 Total Patients Enrolled
17 Trials studying Medulloblastoma
3,535 Patients Enrolled for Medulloblastoma
National Cancer Institute (NCI)NIH
13,633 Previous Clinical Trials
40,928,523 Total Patients Enrolled
86 Trials studying Medulloblastoma
9,793 Patients Enrolled for Medulloblastoma
Ralph SalloumPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Medulloblastoma
50 Patients Enrolled for Medulloblastoma

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05382338 — Phase 3
Medulloblastoma Research Study Groups: Treatment (chemoradiotherapy, maintenance)
Medulloblastoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05382338 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05382338 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
~150 spots leftby Dec 2027