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Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Summary
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
Official title: Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate Via the Ommaya Reservoir in Breast Cancer With Leptomeningeal Metastasis: a Phase II Multicenter Clinical Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
22
Start Date
2024-07-13
Completion Date
2026-12-13
Last Updated
2024-08-09
Healthy Volunteers
No
Interventions
Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir
Patients received intrathecal 15mg MTX combination with 10mg thiotepa twice a week for 2 weeks (4 injections) followed by monthly injections of 15mg MTX combination with 10mg thiotepa until an event that meets the criteria for termination occurs.
Locations (1)
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China