Phase 3
N=131
Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Brain Tumor · Central Nervous System Tumor · Childhood Germ Cell Tumor · Extragonadal Germ Cell Tumor · Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00716976 ↗Enrolled (actual)
131
Serious AEs
35.6%
Results posted
Jun 2017
Primary outcome: Primary: Incidence of Hearing Loss — 14; 31 Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sodium thiosulfate (Drug); examination (Procedure)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Hearing Loss |
14; 31 | — |
| SECONDARY Change in Hearing Thresholds For Key Frequencies at 500 hz |
-1.45; -1.11 | — |
| SECONDARY Change in Hearing Thresholds For Key Frequencies at 1000 hz |
-0.676; -0.319 | — |
| SECONDARY Change in Hearing Thresholds For Key Frequencies at 2000 hz |
-1.18; 0.638 | — |
| SECONDARY Change in Hearing Thresholds For Key Frequencies at 4000 hz |
1.05; 9.58 | — |
| SECONDARY Change in Hearing Thresholds For Key Frequencies at 8000 hz |
9.73; 17.0 | — |
| SECONDARY Event-Free Survival (EFS) |
53.7; 61.4 | — |
| SECONDARY Overall Survival (OS) |
69.6; 82.0 | — |
| SECONDARY Hearing Loss Among Patients Carrying/Not-carrying Two Key Gene Mutations (TPMT and COMT) |
— | — |
Summary
RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss.
PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed (previously untreated or currently receiving cancer treatment for the diagnosis that made the patient eligible for this study) with germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy
- Planning to receive a chemotherapy treatment regimen that includes a cumulative cisplatin dose ≥ 200 mg/m² with individual cisplatin doses to be infused over ≤ 6 hours
- Enrolled on hearing assessment clinical trial COG-ACCL05C1
- Normal auditory results
PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 50-100% (for patients > 16 years of age)
- Lansky PS 50-100% (for patients ≤ 16 years of age)
- Serum sodium normal
- Absolute granulocyte count > 1,000/mm³
- Platelet count > 100,000/mm³
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine between 0.4 and 1.7 mg/dL, based on age and gender
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- AST or ALT < 2.5 times ULN for age
- Not pregnant or nursing
- Negative pregnancy test (if patient has child-bearing capacity)
- Fertile patients must use effective contraception
- No known hypersensitivity to sodium thiosulfate or other thiol agents (e.g., amifostine trihydrate, N-acetylcysteine, MESNA, or captopril)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior platinum-based chemotherapy (cisplatin or carboplatin)
- Other prior chemotherapy allowed
- Prior cranial radiotherapy (e.g., for treatment of medulloblastoma) allowed provided normal hearing is documented after completion of radiotherapy and before enrollment and administration of cisplatin chemotherapy
- At least 6 months since prior hematopoietic stem cell transplantation.
- No evidence of graft-versus-host disease
- No concurrent enrollment on another COG clinical trial for treatment of the cancer.
- Concurrent enrollment on a non-COG clinical trial (e.g., Head start) allowed.
- Cranial irradiation after the completion of all systemic chemotherapy allowed provided post end-of-treatment audiometry is completed prior to beginning irradiation.
- Concurrent radiotherapy to extracranial sites allowed.
Data sourced from ClinicalTrials.gov (NCT00716976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.