Craniospinal Irradiation in Histone AlteRed Midline Glioma (CHARM) - A Phase II Open Label Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Paediatric H3K27/H3G34 mutant diffuse midline gliomas are high grade gliomas that arise in midline structures/cerebral hemispheres and are known to have dismal outcomes. Standard treatment includes definitive radiation therapy to primary site along with concurrent temozolomide chemotherapy following histological confirmation with a biopsy. Studies have shown poorer outcomes in the paediatric age group compared to that of adults and an increased risk to fail/recur in the leptomeninges(covering of brain and spinal cord). The following study is planned in order to assess the benefit of craniospinal irradiation(delivering radiotherapy to brain, spinal cord and its covering membrane in this high risk population. Thereby the investigator aim to improve survival in newly diagnosed histone mutant pediatric midline gliomas in the upfront setting. Patterns of disease failure, treatment related toxicities and quality of life will also be assessed as a part of this study. If proven beneficial, this study will influence how patients with this diagnosis will be treated in the future.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed biopsy proven histone altered diffuse midline glioma

• Age- ≥3 to \<18 years at time of diagnosis

• Karnofsky/Lansky Performance Score more than or equal to 70

• Has provided written informed consent/ assent form

• No prior therapy except debulking surgery or biopsy

Locations
Other Locations
India
Tata Memorial Hospital
RECRUITING
Mumbai
Contact Information
Primary
Abhishek Chatterjee, MD
chatterji08@gmail.com
2224177000
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2028-11-08
Participants
Target number of participants: 32
Treatments
Experimental: Single arm
Craniospinal irradiation involves delivery of radiation therapy to the whole brain, spinal cord, nerve roots, the covering meninges(leptomeninges) and subarachnoid space and provides a viable means of mitigating leptomeningeal spread and possibly improving survival.
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov