Status:
COMPLETED
Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Tumor
Central Nervous System Tumor
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief 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 t...
Detailed 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 tum...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 23 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00716976
Start Date
June 23 2008
End Date
June 30 2021
Last Update
November 9 2023
Active Locations (76)
Enter a location and click search to find clinical trials sorted by distance.
1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027