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.

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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.

View Eligibility Criteria

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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

131

Study ID:

NCT00716976

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 75 Locations for this study

See Locations Near You

UAB Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Childrens Hospital Los Angeles
Los Angeles California, 90027, United States
Southern California Permanente Medical Group
Los Angeles California, 90027, United States
Children's Hospital Central California
Madera California, 93638, United States
Rady Children's Hospital - San Diego
San Diego California, 92123, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Connecticut Children's Medical Center
Hartford Connecticut, 06106, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Alfred I. duPont Hospital for Children
Wilmington Delaware, 19803, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers Florida, 33901, United States
Nemours Children's Clinic
Jacksonville Florida, 32207, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami Florida, 33136, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando Florida, 32803, United States
Nemours Children's Clinic - Orlando
Orlando Florida, 32806, United States
Nemours Children's Clinic - Pensacola
Pensacola Florida, 32504, United States
All Children's Hospital
Saint Petersburg Florida, 33701, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa Florida, 33607, United States
Cancer Research Center of Hawaii
Honolulu Hawaii, 96813, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise Idaho, 83712, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61603, United States
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Kosair Children's Hospital
Louisville Kentucky, 40232, United States
Tulane Cancer Center Office of Clinical Research
Alexandria Louisiana, 71315, United States
Children's Hospital of New Orleans
New Orleans Louisiana, 70118, United States
National Naval Medical Center
Bethesda Maryland, 20889, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis Minnesota, 55404, United States
Masonic Cancer Center at University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City Missouri, 64108, United States
Cardinal Glennon Children's Hospital
Saint Louis Missouri, 63104, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas Nevada, 89109, United States
Hackensack University Medical Center Cancer Center
Hackensack New Jersey, 07601, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87131, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York New York, 10032, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
Duke Cancer Institute
Durham North Carolina, 27710, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Rainbow Babies and Children's Hospital
Cleveland Ohio, 44106, United States
Nationwide Children's Hospital
Columbus Ohio, 43205, United States
Oklahoma University Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States
Knight Cancer Institute at Oregon Health and Science University
Portland Oregon, 97239, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States
Geisinger Cancer Institute at Geisinger Health
Danville Pennsylvania, 17822, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15213, United States
Rhode Island Hospital Comprehensive Cancer Center
Providence Rhode Island, 02903, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
East Tennessee Children's Hospital
Knoxville Tennessee, 37916, United States
Driscoll Children's Hospital
Corpus Christi Texas, 78411, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78207, United States
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane Washington, 99220, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
Princess Margaret Hospital for Children
Perth Western Australia, 6001, Australia
Children's and Women's Hospital of British Columbia
Vancouver British Columbia, V6H 3, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
IWK Health Centre
Halifax Nova Scotia, B3J 3, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon Saskatchewan, S7N 4, Canada
Centre Hospitalier Universitaire de Quebec
Quebec , G1V 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

131

Study ID:

NCT00716976

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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