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Trial Title:
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
NCT ID:
NCT06543992
Condition:
Leptomeningeal Metastasis of Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Meningeal Carcinomatosis
Methotrexate
Thiotepa
Conditions: Keywords:
methotrexate
thiotepa
intrathecal chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir
Description:
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.
Arm group label:
Intrathecal chemotherapy group
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 Reservoir in breast cancer with leptomeningeal metastasis.
The primary end point was iORR [complete response (CR) + partial response (PR)] according
to RANO-LM. Scoring based on radiographic assessment in leptomeningeal metastases . A
composite score (total score) is calculated and compared with the baseline total score. A
25% worsening in the current score relative to baseline defines radiographic progressive
disease. A 50% improvement in the current score defines a radiographic partial response.
Resolution of all baseline radiographic abnormalities defines a complete response. All
other situations define stable disease. The secondary end points were changes in iPFS,
iDoR, ORR, PFS, OS, DoR and exploratory analysis of the relationship between molecular
markers and therapeutic efficacy.
This study is planned to include 22 patients with leptomeningeal metastasis from breast
cancer who meet the entry criteria.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.
2. ECGO rating 0-3.
3. Histologically or cytologically confirmed breast cancer.
4. Cerebrospinal fluid cytology combined with central nervous system function and brain
imaging demonstrated the diagnosis of breast cancer with meningeal metastases;
5. Patients can be implanted or have been implanted with Ommaya reservoirs;
6. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria);
7. 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.
8. 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 Criteria:
1. Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma
in situ
2. Patients with severe or uncontrolled systemic disease, including uncontrolled
hypertension or active bleeding tendency
3. The investigator considers the patient unsuitable for entry into this study.
4. Patients with toxicity from prior therapy that has not returned to normal or
NCI-CTCAE grade 5.0
5. Patients who have a drug allergy or metabolic disorder to the drugs in this regimen
6. 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).
7. Patients who are concurrently enrolled in other clinical studies
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Li, Ph.D
Phone:
25-68307102
Email:
real.lw@163.com
Investigator:
Last name:
Wei Li, Ph.D
Email:
Principal Investigator
Start date:
July 13, 2024
Completion date:
December 13, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Brain Hospital of Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06543992
