Ovarian Cancer Clinical Trial
Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
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.
Full 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.
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.
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There are 75 Locations for this study
Birmingham Alabama, 35294, United States
Little Rock Arkansas, 72205, United States
Los Angeles California, 90027, United States
Los Angeles California, 90027, United States
Madera California, 93638, United States
San Diego California, 92123, United States
San Francisco California, 94115, United States
Hartford Connecticut, 06106, United States
New Haven Connecticut, 06520, United States
Wilmington Delaware, 19803, United States
Washington District of Columbia, 20010, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32207, United States
Miami Florida, 33136, United States
Orlando Florida, 32803, United States
Orlando Florida, 32806, United States
Pensacola Florida, 32504, United States
Saint Petersburg Florida, 33701, United States
Tampa Florida, 33607, United States
Honolulu Hawaii, 96813, United States
Boise Idaho, 83712, United States
Chicago Illinois, 60612, United States
Peoria Illinois, 61603, United States
Indianapolis Indiana, 46202, United States
Des Moines Iowa, 50309, United States
Iowa City Iowa, 52242, United States
Louisville Kentucky, 40232, United States
Alexandria Louisiana, 71315, United States
New Orleans Louisiana, 70118, United States
Bethesda Maryland, 20889, United States
Ann Arbor Michigan, 48109, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Minneapolis Minnesota, 55404, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Kansas City Missouri, 64108, United States
Saint Louis Missouri, 63104, United States
Las Vegas Nevada, 89109, United States
Hackensack New Jersey, 07601, United States
Newark New Jersey, 07112, United States
Albuquerque New Mexico, 87131, United States
New York New York, 10032, United States
Syracuse New York, 13210, United States
Charlotte North Carolina, 28233, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45229, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43205, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97227, United States
Portland Oregon, 97239, United States
Bethlehem Pennsylvania, 18017, United States
Danville Pennsylvania, 17822, United States
Pittsburgh Pennsylvania, 15213, United States
Providence Rhode Island, 02903, United States
Sioux Falls South Dakota, 57117, United States
Knoxville Tennessee, 37916, United States
Corpus Christi Texas, 78411, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78207, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23298, United States
Spokane Washington, 99220, United States
Green Bay Wisconsin, 54307, United States
Marshfield Wisconsin, 54449, United States
Perth Western Australia, 6001, Australia
Vancouver British Columbia, V6H 3, Canada
Winnipeg Manitoba, R3E 0, Canada
Halifax Nova Scotia, B3J 3, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Quebec , G1V 4, Canada
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