Actively Recruiting
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-08-09
22
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
T
The Affiliated Brain Hospital of Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
CONDITIONS
Official Title
Efficacy and Safety of Intrathecal Administration of Thiotepa in Combination With Methotrexate in Breast Cancer With Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged between 18 and 75 years at the time of consent
- ECOG performance status of 0 to 3
- Histologically or cytologically confirmed breast cancer
- Diagnosis of leptomeningeal metastases confirmed by cerebrospinal fluid cytology, central nervous system function, and brain imaging
- Patients implanted or able to be implanted with an Ommaya Reservoir
- At least one measurable lesion as per RECIST 1.1 criteria
- Postmenopausal females or pre/perimenopausal females willing to receive LHRHa during the study
- Laboratory values prior to enrollment: Hb ≥90 g/L, WBC ≥3.5×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, liver function within specified limits depending on liver metastases status
You will not qualify if you...
- Presence of other malignant tumors except basal cell carcinoma and carcinoma in situ
- Severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding tendencies
- Investigator deems patient unsuitable for the study
- Unresolved toxicity from prior therapy at or above NCI-CTCAE grade 5.0
- Allergy or metabolic disorder to study drugs
- Pregnant or lactating women; women of childbearing age must have negative pregnancy test within 14 days before first dose
- Concurrent enrollment in other clinical studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
W
Wei Li, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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