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RECRUITING
NCT06543992
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

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