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Clinical trials
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- Active clinical trials for pediatric cancers
- CAR-20/19-T cells in pediatric and young adult patients with relapsed/refractory B Cell Acute Lymphoblastic Leukemia (CAR-20/19-T) phase 1 clinical trial
- Unrelated and partially matched related donor peripheral stem cell transplantation for patients with hematologic malignancies clinical trial
- Early stage research
Active clinical trials
Cancer Clinical Trials - COG-ACNS2031
Protocol Summary
- Protocol No
- COG-ACNS2031
- Principal Investigator
- Sarah Rumler
- Phase
- III
- Title
- A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy in Children with Medulloblastoma with Low-Risk Features
- Associated Disease(s)
-
Brain and Spinal Cord Tumors
- Description (Summary)
- This study looks at adding STS to standard treatment for MB (radiation therapy and chemotherapy, including cisplatin) to find out if it reduces hearing loss. Pedmark® brand is the only STS product that is FDA-approved to reduce the risk of hearing loss caused by cisplatin in children with solid tumors that have not spread to other parts of the body. STS has been shown to be well-tolerated in children and adults, and other studies of STS have shown that it helps reduce or prevent hearing loss caused by cisplatin. STS has not been used in a large group of patients with MB and its impact on the tumor’s response to MB treatment is not fully known.
In addition, this study looks at how well a reduced dose of radiation works when given to children and young adults with low-risk MB. Study doctors would like to try to reduce side effects of treatment by giving a smaller dose of radiation therapy to low-risk subjects. The side effects caused by radiation include learning difficulties or other problems in performing daily activities, lower amounts of hormones, and very rarely other cancers that can occur years after treatment.
The overall goals of this study are to:
• See if giving STS along with standard treatment for MB (radiation therapy and chemotherapy) will reduce hearing loss.
• Compare the overall outcome of patients with MB treated with STS to patients treated without STS on a previous study in order to make sure that survival and recurrence of tumor is not worsened.
- Participating Institutions
- Childrens Hospital of Wisconsin
- ClinicalTrials.gov
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