All > Iowa > Medulloblastoma

Arm I (Average-Risk) for Hearing Loss

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Rady Children's Hospital - San Diego, San Diego, CAHearing Loss+3 MoreSodium Thiosulfate - Drug
Eligibility
3 - 21
All Sexes
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Study Summary

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

Eligible Conditions
  • Medulloblastoma
  • Hearing Loss due to Drug Toxicity

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Stratum 2A- Regimen CSS
1
Experimental arm with Intratympanic NAC injection
1
Cisplatin

Study Objectives

3 Primary · 20 Secondary · Reporting Duration: Up to 10 years

Week 4
The percentage of patients with ≥ Grade 2 hearing loss
Year 5
Blood and Cerebrospinal Fluid Banking for future studies
EFS for patients with low-risk features treated using a reduced craniospinal radiation approach
Medulloblastoma
Hearing related-quality of life (HEAR-QL) of patients with low-risk features treated using a reduced craniospinal radiation approach
Incidence of cisplatin-related nephrotoxicity in both the average-risk and low-risk cohorts: Mean
Incidence of cisplatin-related nephrotoxicity in both the average-risk and low-risk cohorts: Median
Incidence of ototoxicity-related cisplatin dose modifications in the average-risk cohort: Mean
Incidence of ototoxicity-related cisplatin dose modifications in the average-risk cohort: Median
OS for patients with low-risk features treated using a reduced craniospinal
Overall Survival (OS)
Paired blood and Tumor Tissue Banking for future studies
Week 4
Percentage of patients with >= grade 2 hearing loss
Year 10
Event-free survival (EFS)
Month 60
The number of medulloblastoma patients with ≥ Grade 2 hearing loss treated with STS
Up to 10 years
EFS in patients with low-risk features treated using a reduced craniospinal radiation approach
Frequency of cisplatin-related nephrotoxicity
Incidence of cisplatin-related nephrotoxicity in both the average-risk and low-risk cohorts
Incidence of ototoxicity-related cisplatin dose modifications in the average-risk cohort
OS in patients with low-risk features treated using a reduced craniospinal radiation approach
Overall survival (OS)
Up to 5 years
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
Medulloblastoma
HEAR-QL of patients with low-risk features treated using a reduced craniospinal radiation approach
Hearing related-quality of life (HEAR-QL) of patients with average-risk medulloblastoma treated with STS
Paired blood and tumor tissue banking or future studies
Quality of life and psychosocial outcomes of patients with average-risk medulloblastoma treated with STS
Up to 60 months
Number of medulloblastoma patients with >= grade 2 hearing loss treated with STS
Trajectory of hearing loss medulloblastoma patients treated with STS
Month 60
Household material hardship as a social determinant of neurocognitive, quality of life, and psychosocial outcomes in patients with average-risk and low-risk medulloblastoma

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Stratum 2A- Regimen CSS
1
Experimental arm with Intratympanic NAC injection
2
Cisplatin

Trial Design

3 Treatment Groups

Arm I (Average-Risk)
1 of 3
Arm II (Low-Risk)
1 of 3
Treatment (chemoradiotherapy, maintenance)
1 of 3

Experimental Treatment

225 Total Participants · 3 Treatment Groups

Primary Treatment: Arm I (Average-Risk) · No Placebo Group · Phase 3

Arm I (Average-Risk)Experimental Group · 9 Interventions: Questionnaire Administration, Sodium thiosulfate, Chemoradiotherapy, Cisplatin, Cyclophosphamide, Vincristine, Lomustine, Mesna, Quality-of-Life Assessment · Intervention Types: Other, Drug, Radiation, Drug, Drug, Drug, Drug, Drug, Other
Arm II (Low-Risk)Experimental Group · 9 Interventions: Questionnaire Administration, Sodium thiosulfate, Chemoradiotherapy, Cisplatin, Cyclophosphamide, Vincristine, Lomustine, Mesna, Quality-of-Life Assessment · Intervention Types: Other, Drug, Radiation, Drug, Drug, Drug, Drug, Drug, Other
Treatment (chemoradiotherapy, maintenance)Experimental Group · 9 Interventions: Sodium Thiosulfate, Cisplatin, Cyclophosphamide, Survey Administration, Vincristine, Lomustine, Mesna, Quality-of-Life Assessment, Radiation Therapy · Intervention Types: Drug, Drug, Drug, Other, Drug, Drug, Drug, Other, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Thiosulfate
2014
Completed Phase 2
~60
Sodium thiosulfate
2009
Completed Phase 2
~50
Chemoradiotherapy
2010
Completed Phase 3
~310
Cisplatin
2013
Completed Phase 3
~1920
Cyclophosphamide
1995
Completed Phase 3
~3920
Vincristine
2003
Completed Phase 4
~2920
Lomustine
2008
Completed Phase 3
~1550
Mesna
2003
Completed Phase 2
~1350
Radiation Therapy
2017
Completed Phase 3
~7130

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
451 Previous Clinical Trials
236,846 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,083 Total Patients Enrolled
Ralph SalloumPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
50 Total Patients Enrolled

Eligibility Criteria

Age 3 - 21 · All Participants · 31 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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