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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.

• ECGO rating 0-3.

• Histologically or cytologically confirmed breast cancer.

• Cerebrospinal fluid cytology combined with central nervous system function and brain imaging demonstrated the diagnosis of breast cancer with meningeal metastases;

• Patients can be implanted or have been implanted with Ommaya reservoirs;

• Patient must have at least one measurable lesion (according to RECIST 1.1 criteria);

• Postmenopausal or pre/perimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period.

• All patients were required to meet the following laboratory biochemical values prior to enrolment:

‣ Haematology: Hb ≥90 g/L, WBC ≥3.5×109/L, ANC ≥1.5×109/L, PLT ≥100×109/L;

⁃ Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times the upper limit of normal values, and ≤1.25 x the upper limit of normal values for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of normal value.

Locations
Other Locations
China
Jiangsu Provincial People's Hospital
RECRUITING
Nanjing
Contact Information
Primary
Wei Li, Ph.D
real.lw@163.com
025-68307102
Time Frame
Start Date: 2024-07-13
Estimated Completion Date: 2026-12-13
Participants
Target number of participants: 22
Treatments
Experimental: Intrathecal chemotherapy group
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.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Brain Hospital of Nanjing Medical University
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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