Overview

This trial is active, not recruiting.

Conditions brain tumor, central nervous system tumor, childhood germ cell tumor, extragonadal germ cell tumor, liver cancer, neuroblastoma, ototoxicity, ovarian cancer, sarcoma
Treatments sodium thiosulfate, examination
Phase phase 3
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date June 2008
End date September 2012
Trial size 131 participants
Trial identifier NCT00716976, ACCL0431, CDR0000588655, COG-ACCL0431

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.
sodium thiosulfate ADH300001
Given IV
examination
Patients undergo audiological assessments periodically
(Experimental)
Patients do not receive sodium thiosulfate.
examination
Patients undergo audiological assessments periodically

Primary Outcomes

Measure
Incidence of hearing loss
time frame: 4 weeks after last dose of cisplatin

Secondary Outcomes

Measure
Change in hearing thresholds for key frequencies
time frame: 4 weeks after last dose of cisplatin
Event-free-survival
time frame: Up to 10 years
Overall survival
time frame: Up to 10 years
Hearing loss among patients carrying/not-carrying two key gene mutations (TPMT and COMT)
time frame: 4 weeks after the last dose of cisplatin

Eligibility Criteria

Male or female participants from 1 year up to 18 years old.

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.

Additional Information

Official title A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
Description OBJECTIVES: Primary - To compare the efficacy of sodium thiosulfate vs observation in preventing hearing loss in young patients receiving cisplatin for the treatment of newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy. Secondary - To compare the mean change in hearing thresholds for key frequencies in these patients. - To compare the incidences of cisplatin-related grade 3 and 4 nephrotoxicity and grade 3 and 4 cytopenia in these patients. - To compare the event-free survival and overall survival of these patients. - To evaluate the association of two key gene mutations (TPMT and COMT) with the development of cisplatin-induced hearing loss in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior cranial radiation (yes vs no), age (< 5 years vs ≥ 5 years) and duration of cisplatin infusion (< 2 hours vs ≥ 2 hours). Patients are randomized to 1 of 2 arms. - Arm I (sodium thiosulfate): Patients receive sodium thiosulfate IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy. - Arm II (observation): Patients do not receive sodium thiosulfate. Patients undergo audiological assessment at baseline, prior to each course of cisplatin, and then at 4 weeks and 1 year after the last course of cisplatin or other cancer treatment. Some patients may undergo saliva collection for DNA studies. After completion of study, patients are followed periodically for 10 years.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Children's Oncology Group.