Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC

Launched by SHANGHAI CHEST HOSPITAL · Oct 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) who have developed leptomeningeal metastases. This means that the cancer has spread to the membranes surrounding the brain and spinal cord. The trial is looking at the safety and effectiveness of combining two medications, Pemetrexed and Bevacizumab, which will be given through an injection into the spinal fluid.

To be eligible for this trial, participants need to be at least 18 years old and have been diagnosed with NSCLC that has spread to the brain or spinal cord. They should also have had limited success with standard cancer treatments and expect to live for at least one more month. Participants will need to undergo some health checks to ensure they can safely receive the treatment. If they join the study, they will receive the new treatment and be closely monitored by the research team to assess how well it works and if there are any side effects. This study is currently looking for volunteers to participate, and it's important for those interested to discuss it with their healthcare team to see if they qualify.

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years;
• • ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases.
• • Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM);
• • Unsatisfactory efficacy of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment;
• • Expected survival time ≥ 1 month;
• • The laboratory test results meet the following criteria:Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN ; Creatinine≤ 2.0 × ULN,or Creatinine clearance rate (CrCl) ≥ 50 mL/min;
• • Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study;
• • Understand and sign the informed consent form.
• Exclusion Criteria:
• • Positive for human immunodeficiency virus (HIV) ;
• • History of allergy to pemetrexed or bevacizumab;
• • History of pemetrexed and/or bevacizumab intrathecal Injection;
• * Presence of contraindication of bevacizumab:
• • 1. Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy;
• • 2. Urine protein≥2+,or 24-hour urine protein≥2g；
• • 3. Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia;
• • 4. Major hemoptysis within the past 1 month; History of coagulation disorders;
• • 5. Presence of serious non-healing wounds, ulcers, or bone fractures
• • 6. Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction;
• • 7. Presence of macrovascular invasion；
• • 8. Some neurological disorders unrelated to tumors，such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis;
• • Brain/spinal cord radiation therapy within 1 week before enrollment;
• • Pregnant and lactating female;
• • Refuse to use contraception during the study period;
• • Individuals considered by the investigator to be unsuitable for enrollment.