View Clinical Trial (Medical Research Study)
A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06520 |
| Conditions: |
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Brain and Central Nervous System Tumors - Childhood Germ Cell Tumor - Extragonadal Germ Cell Tumor - Liver Cancer - Neuroblastoma - Ototoxicity - Ovarian Cancer - Sarcoma |
| Purpose: |
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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 compared with no additional treatment 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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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00716976 |
| Primary Contact: |
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Study Chair
David R. Freyer, DO, MS
Children's Hospital Los Angeles
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Haven, Connecticut 06520
United States
Clinical Trials Office - Yale Cancer Center
Phone: 203-785-5702
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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