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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
2024-08-08
Completion Date
2026-12-13
Last Updated
2026-07-21
Healthy Volunteers
No
Interventions
Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir
Patients received 15 mg MTX intrathecally combined with 10 mg thiotepa twice a week for 2 weeks (4 injections), followed by a maintenance phase in which the same agents and dosages were administered every three weeks until an event meeting the termination criteria occurs.
Locations (1)
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China