RecruitingPhase 2NCT06543992

Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

22 participants

Start Date

Jul 13, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting two chemotherapy drugs — thiotepa and methotrexate — directly into the fluid around the brain (intrathecal route) can help women with breast cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal metastasis). **You may be eligible if...** - You are a woman aged 18–75 with confirmed breast cancer - Your cancer has spread to the membranes surrounding the brain/spinal cord - You can have or already have an Ommaya reservoir (a small device implanted under the scalp for drug delivery) - You have at least one measurable lesion - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - Your general health is severely declined - You have significant active brain bleeding or uncontrolled infection - You cannot tolerate the required procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntrathecal 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

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NCT06543992


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