|Phase III||Biomarker/Laboratory analysis, Supportive care||Closed||1 to 18||NCI, Other||ACCL0431|
COG-ACCL0431, CDR0000588655, NCT00716976
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.
Further Study Information
- 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.
- 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.
- 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
- 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
- Amendment #1A dated 3/31/2010 was implemented in order to address the following: expansion of the eligibility criteria to include children who have received cranial irradiation prior to enrollment onto ACCL0431; expansion of the eligibility criteria to include children with newly diagnosed malignancy treated with cisplatin; addition of an optional biology study as a secondary objective; addition of futility monitoring of the primary endpoint.
Prior to Amendment #1A:
- 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
Trial Lead Organizations/Sponsors
Children's Oncology GroupNational Cancer Institute
|David Robert Freyer||Study Chair|
|Lucile Packard Children's Hospital at Stanford University Medical Center|
|Neyssa M Marina||Ph: 650-498-7061|
|Western Michigan University School of Medicine Clinics|
|Jeffrey S Lobel||Ph: 800-227-2345|
|Cleveland Clinic Taussig Cancer Center|
|Tanya M Tekautz||Ph: 866-223-8100|
|Legacy Emanuel Hospital and Health Center and Children's Hospital|
|Janice F Olson||Ph: 503-413-8199|
|Children's Hospital of Eastern Ontario|
|Jacqueline M Halton||Ph: 613-738-3931|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00716976
ClinicalTrials.gov processed this data on December 03, 2013
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