Intrathecal treatment for lung cancer with leptomeningeal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of combining Pemetrexed and Bevacizumab delivered via intrathecal injection in patients suffering from leptomeningeal metastases due to non-small cell lung cancer (NSCLC). It is a prospective, single-arm, phase 1 study aimed at patients who have shown inadequate response to standard systemic treatments. The study will assess the impact of this novel approach on disease progression and neurological symptoms associated with leptomeningeal metastases.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Hua Zhong, MD
• Email: eddiedong8@hotmail.com
• Phone: +86 021-22200000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.