Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00716976 : Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
PhasePhase 3
AgesMin: 1 Year Max: 18 Years
Eligibility
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., Headstart) allowed

- No concurrent cranial irradiation during the chemotherapy regimen (i.e., prior to the
administration of the final dose of cisplatin)

- 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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT00716976      |      Link to official Clinicaltrials.gov listing
Locations
Perth, Western Australia
Australia

Facility: Princess Margaret Hospital for Children
Investigator:
Contact: Catherine H. Cole Phone: 011-6189340-8238
Email not avaialable

Quebec,
Canada

Facility: Centre Hospitalier Universitaire de Quebec
Investigator:
Contact: Bruno Michon Phone: 418-656-4141X47191
Email not avaialable

Vancouver, British Columbia
Canada

Facility: Children's and Women's Hospital of British Columbia
Investigator:
Contact: Caron Strahlendorf Phone: 604-875-3576
Email not avaialable

Winnipeg, Manitoba
Canada

Facility: CancerCare Manitoba
Investigator:
Contact: Rochelle A. Yanofsky Phone: 204-787-4163
Email not avaialable

Halifax, Nova Scotia
Canada

Facility: IWK Health Centre
Investigator:
Contact: Margaret C. Yhap Phone: 902-470-8778
Email not avaialable

Ottawa, Ontario
Canada

Facility: Children's Hospital of Eastern Ontario
Investigator:
Contact: Jacqueline M.L. Halton Phone: 613-737-7600x2370
Email not avaialable

Toronto, Ontario
Canada

Facility: Hospital for Sick Children
Investigator:
Contact: Sylvain Baruchel Phone: 416-813-7795
Email not avaialable

Montreal, Quebec
Canada

Facility: Hopital Sainte Justine
Investigator:
Contact: Yvan Samson Phone: 514-345-4931x2790
Email not avaialable

Saskatoon, Saskatchewan
Canada

Facility: Saskatoon Cancer Centre at the University of Saskatchewan
Investigator:
Contact: Christopher Mpofu Phone: 306-655-2744
Email not avaialable

Birmingham, Alabama
Facility: UAB Comprehensive Cancer Center
Investigator:
Contact: Clinical Trials Office - UAB Comprehensive Cancer Center Phone: 205-934-0309
Email not avaialable

Little Rock, Arkansas
Facility: Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Investigator:
Contact: Clinical Trial Office - Arkansas Cancer Research Center at Uni Phone: 501-686-8274
Email not avaialable

Los Angeles, California
Facility: Childrens Hospital Los Angeles
Investigator:
Contact: Leo Mascarenhas Phone: 323-361-2529
Email not avaialable

Los Angeles, California
Facility: Southern California Permanente Medical Group
Investigator:
Contact: Robert M. Cooper Phone: 323-783-5307
Email not avaialable

Madera, California
Facility: Children's Hospital Central California
Investigator:
Contact: Vonda L. Crouse Phone: 559-353-5480
Email not avaialable

San Diego, California
Facility: Rady Children's Hospital - San Diego
Investigator:
Contact: Clinical Trials Office - Rady Children's Hospital - San Diego Phone: 858-966-5934
Email not avaialable

San Francisco, California
Facility: UCSF Helen Diller Family Comprehensive Cancer Center
Investigator:
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi Phone: 877-827-3222
Email not avaialable

Hartford, Connecticut
Facility: Connecticut Children's Medical Center
Investigator:
Contact: Clinical Trials Office - Connecticut Children's Medical Center Phone: 860-545-9967
Email not avaialable

New Haven, Connecticut
Facility: Yale Cancer Center
Investigator:
Contact: Clinical Trials Office - Yale Cancer Center Phone: 203-785-5702
Email not avaialable

Wilmington, Delaware
Facility: Alfred I. duPont Hospital for Children
Investigator:
Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre Phone: 302-651-5755
Email not avaialable

Washington, District of Columbia
Facility: Children's National Medical Center
Investigator:
Contact: Clinical Trials Office - Children's National Medical Center Phone: 202-884-2549
Email not avaialable

Fort Myers, Florida
Facility: Lee Cancer Care of Lee Memorial Health System
Investigator:
Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt Phone: 877-680-0008
Email not avaialable

Jacksonville, Florida
Facility: Nemours Children's Clinic
Investigator:
Contact: Eric S. Sandler Phone: 904-697-3793
Email not avaialable

Miami, Florida
Facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
Investigator:
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin Phone: 866-574-5124
Click HERE to send email to this center

Orlando, Florida
Facility: Nemours Children's Clinic - Orlando
Investigator:
Contact: Ramamoorthy Nagasubramanian Phone: 407-650-7230
Email not avaialable

Orlando, Florida
Facility: Florida Hospital Cancer Institute at Florida Hospital Orlando
Investigator:
Contact: Clinical Trials Office - Florida Hospital Cancer Institute Phone: 407-303-5623
Email not avaialable

Pensacola, Florida
Facility: Nemours Children's Clinic - Pensacola
Investigator:
Contact: Jeffrey H. Schwartz Phone: 850-505-4790
Email not avaialable

Saint Petersburg, Florida
Facility: All Children's Hospital
Investigator:
Contact: Gregory A. Hale Phone: 727-767-4176
Email not avaialable

Tampa, Florida
Facility: St. Joseph's Cancer Institute at St. Joseph's Hospital
Investigator:
Contact: Clinical Trials Office - St. Joseph's Cancer Institute Phone: 800-882-4123
Email not avaialable

Honolulu, Hawaii
Facility: Cancer Research Center of Hawaii
Investigator:
Contact: Clinical Trials Office - Cancer Research Center of Hawaii Phone: 808-586-2979
Email not avaialable

Boise, Idaho
Facility: Mountain States Tumor Institute at St. Luke's Regional Medical Center
Investigator:
Contact: Eugenia Chang Phone: 208-381-2731
Email not avaialable

Chicago, Illinois
Facility: University of Illinois Cancer Center
Investigator:
Contact: Clinical Trial Office - University of Illinois Cancer Center Phone: 312-355-3046
Email not avaialable

Peoria, Illinois
Facility: Saint Jude Midwest Affiliate
Investigator:
Contact: Pedro A. De Alarcon Phone: 309-655-4242
Email not avaialable

Indianapolis, Indiana
Facility: Riley's Children Cancer Center at Riley Hospital for Children
Investigator:
Contact: James M. Croop Phone: 317-944-8784
Email not avaialable

Des Moines, Iowa
Facility: Blank Children's Hospital
Investigator:
Contact: Clinical Trials Office - Blank Children's Hospital Phone: 515-241-6729
Email not avaialable

Iowa City, Iowa
Facility: Holden Comprehensive Cancer Center at University of Iowa
Investigator:
Contact: Cancer Information Service Phone: 800-237-1225
Email not avaialable

Louisville, Kentucky
Facility: Kosair Children's Hospital
Investigator:
Contact: Clinical Trials Office - Kosair Children's Hospital Phone: 502-629-5500
Click HERE to send email to this center

Alexandria, Louisiana
Facility: Tulane Cancer Center Office of Clinical Research
Investigator:
Contact: Clinical Trials Office - Tulane Cancer Center Phone: 504-988-6121
Email not avaialable

New Orleans, Louisiana
Facility: Children's Hospital of New Orleans
Investigator:
Contact: Clinical Trials Office - Children's Hospital of New Orleans Phone: 504-894-5377
Email not avaialable

Bethesda, Maryland
Facility: National Naval Medical Center
Investigator:
Contact: Melissa A. Forouhar Phone: 253-968-6144
Email not avaialable

Ann Arbor, Michigan
Facility: C.S. Mott Children's Hospital at University of Michigan Medical Center
Investigator:
Contact: Clinical Trials Office - C.S. Mott Children's Hospital Phone: 800-865-1125
Email not avaialable

Flint, Michigan
Facility: Hurley Medical Center
Investigator:
Contact: Clinical Trials Office - Hurley Medical Center Phone: 810-762-8057
Email not avaialable

Grand Rapids, Michigan
Facility: Helen DeVos Children's Hospital at Spectrum Health
Investigator:
Contact: Clinical Trials Office - Helen DeVos Children's Hospital Phone: 616-391-3050
Email not avaialable

Kalamazoo, Michigan
Facility: Bronson Methodist Hospital
Investigator:
Contact: Jeffrey S. Lobel Phone: 269-341-6350
Email not avaialable

Minneapolis, Minnesota
Facility: Children's Hospitals and Clinics of Minnesota - Minneapolis
Investigator:
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M Phone: 612-813-5193
Email not avaialable

Minneapolis, Minnesota
Facility: Masonic Cancer Center at University of Minnesota
Investigator:
Contact: Clinical Trials Office - Masonic Cancer Center at University o Phone: 612-624-2620
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic Cancer Center
Investigator:
Contact: Clinical Trials Office - All Mayo Clinic Locations Phone: 507-538-7623
Email not avaialable

Kansas City, Missouri
Facility: Children's Mercy Hospital
Investigator:
Contact: Maxine L. Hetherington Phone: 816-234-3265
Email not avaialable

St. Louis, Missouri
Facility: Cardinal Glennon Children's Hospital
Investigator:
Contact: William S. Ferguson Phone: 314-577-5638
Email not avaialable

Las Vegas, Nevada
Facility: CCOP - Nevada Cancer Research Foundation
Investigator:
Contact: Jonathan Bernstein Phone: 702-732-1493
Email not avaialable

Hackensack, New Jersey
Facility: Hackensack University Medical Center Cancer Center
Investigator:
Contact: Clinical Trials Office - Hackensack University Medical Center Phone: 201-996-2879
Email not avaialable

Newark, New Jersey
Facility: Newark Beth Israel Medical Center
Investigator:
Contact: Clinical Trials Office - Newark Beth Israel Medical Center Phone: 973-926-3136
Email not avaialable

Albuquerque, New Mexico
Facility: University of New Mexico Cancer Center
Investigator:
Contact: Clinical Trials Office - University of New Mexico Cancer Cente Phone: 505-272-6972
Email not avaialable

New York, New York
Facility: Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Investigator:
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C Phone: 212-305-8615
Email not avaialable

Syracuse, New York
Facility: SUNY Upstate Medical University Hospital
Investigator:
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi Phone: 315-464-5476
Email not avaialable

Charlotte, North Carolina
Facility: Presbyterian Cancer Center at Presbyterian Hospital
Investigator:
Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt Phone: 704-384-5369
Email not avaialable

Durham, North Carolina
Facility: Duke Cancer Institute
Investigator:
Contact: Clinical Trials Office - Duke Cancer Institute Phone: 888-275-3853
Email not avaialable

Winston-Salem, North Carolina
Facility: Wake Forest University Comprehensive Cancer Center
Investigator:
Contact: Clinical Trials Office - Wake Forest University Comprehensive Phone: 336-713-6771
Email not avaialable

Cincinnati, Ohio
Facility: Cincinnati Children's Hospital Medical Center
Investigator:
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica Phone: 513-636-2799
Email not avaialable

Cleveland, Ohio
Facility: Rainbow Babies and Children's Hospital
Investigator:
Contact: Yousif (Joe) H. Matloub Phone: 216-844-3345
Email not avaialable

Columbus, Ohio
Facility: Nationwide Children's Hospital
Investigator:
Contact: Laura T. Martin Phone: 614-722-3582
Email not avaialable

Oklahoma City, Oklahoma
Facility: Oklahoma University Cancer Institute
Investigator:
Contact: Rene Y. McNall-Knapp Phone: 405-271-5311
Email not avaialable

Portland, Oregon
Facility: Knight Cancer Institute at Oregon Health and Science University
Investigator:
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea Phone: 503-494-1080
Click HERE to send email to this center

Portland, Oregon
Facility: Legacy Emanuel Children's Hospital
Investigator:
Contact: Clinical Trials Office - Legacy Emanuel Children's Hospital Phone: 503-413-2560
Email not avaialable

Bethlehem, Pennsylvania
Facility: Lehigh Valley Hospital - Muhlenberg
Investigator:
Contact: Philip M. Monteleone Phone: 484-884-3333
Email not avaialable

Danville, Pennsylvania
Facility: Geisinger Cancer Institute at Geisinger Health
Investigator:
Contact: Clinical Trials Office - Geisinger Cancer Institute Phone: 570-271-5251
Email not avaialable

Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator:
Contact: Clinical Trials Office - Children's Hospital of Pittsburgh Phone: 412-692-7056
Email not avaialable

Providence, Rhode Island
Facility: Rhode Island Hospital Comprehensive Cancer Center
Investigator:
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C Phone: 401-444-1488
Email not avaialable

Sioux Falls, South Dakota
Facility: Sanford Cancer Center at Sanford USD Medical Center
Investigator:
Contact: Clinical Trials Office - Sanford Cancer Center Phone: 605-328-1367
Email not avaialable

Knoxville, Tennessee
Facility: East Tennessee Children's Hospital
Investigator:
Contact: Ray C. Pais Phone: 865-541-8266
Email not avaialable

Corpus Christi, Texas
Facility: Driscoll Children's Hospital
Investigator:
Contact: Clinical Trials Office - Driscoll Children's Hospital Phone: 361-694-5311
Email not avaialable

Dallas, Texas
Facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Investigator:
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a Phone: 866-460-4673; 214-648-7097
Email not avaialable

San Antonio, Texas
Facility: University of Texas Health Science Center at San Antonio
Investigator:
Contact: Anne-Marie R. Langevin Phone: 210-567-7477
Email not avaialable

Norfolk, Virginia
Facility: Children's Hospital of The King's Daughters
Investigator:
Contact: Eric J. Lowe Phone: 757-668-7243
Email not avaialable

Richmond, Virginia
Facility: Virginia Commonwealth University Massey Cancer Center
Investigator:
Contact: Clinical Trials Office -Virginia Commonwealth University Masse Phone: 804-628-1939
Email not avaialable

Spokane, Washington
Facility: Providence Cancer Center at Sacred Heart Medical Center
Investigator:
Contact: Judy L. Felgenhauer Phone: 509-474-2777
Email not avaialable

Green Bay, Wisconsin
Facility: St. Vincent Hospital Regional Cancer Center
Investigator:
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer Phone: 920-433-8889
Email not avaialable

Marshfield, Wisconsin
Facility: Marshfield Clinic - Marshfield Center
Investigator:
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center Phone: 800-782-1581 ext. 94457
Email not avaialable




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