Sodium Thiosulfate 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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Brief Title

Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy

Official Title

A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Incidence of Hearing Loss

Secondary Outcome

 Change in Hearing Thresholds For Key Frequencies at 500 hz

Condition

Brain Tumor

Intervention

sodium thiosulfate

Study Arms / Comparison Groups

 STS Arm (sodium thiosulfate treatment)
Description:  Patients receive sodium thiosulfate IV (dosage 16 g/m2 or 533 mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body) over 15 minutes beginning 6 hours after the completion of each cisplatin infusion. Treatment with sodium thiosulfate continues until the completion of cisplatin therapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

131

Start Date

June 2008

Completion Date

April 9, 2015

Primary Completion Date

April 2015

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.
      

Gender

All

Ages

1 Year - 18 Years

Accepts Healthy Volunteers

No

Contacts

David R. Freyer, DO, MS, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00716976

Organization ID

ACCL0431

Secondary IDs

COG-ACCL0431

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

David R. Freyer, DO, MS, Study Chair, Children's Hospital Los Angeles


Verification Date

August 2018