Status:
RECRUITING
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
The Affiliated Brain Hospital of Nanjing Medical University
Conditions:
Leptomeningeal Metastasis of Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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
Detailed Description
This was a II, single-arm, prospective, multicenter study designed to estimate the efficacy and safety of intrathecal administration of thiotepa in combination with methotrexate via the Ommaya Reservo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ
- Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency
- The investigator considers the patient unsuitable for entry into this study.
- Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0
- Patients who have a drug allergy or metabolic disorder to the drugs in this regimen
- Pregnant or lactating women (women of childbearing age must have had a negative pregnancy test within 14 days prior to the first dose; if positive, pregnancy must be ruled out by ultrasound).
- Patients who are concurrently enrolled in other clinical studies
Key Trial Info
Start Date :
July 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 13 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06543992
Start Date
July 13 2024
End Date
December 13 2026
Last Update
August 9 2024
Active Locations (1)
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1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000