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Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Leptomeningeal Metastases

ConditionLeptomeningeal Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital

About this trial

With the rapid development of targeted drugs, the treatment of patients with leptomeningeal metastasis has become a very difficult problem in clinical work. High-dose targeted drugs and intrathecal chemotherapy are important treatment methods for meningeal metastasis. However, it is vital to note that safety is also of concern in previous studies of intrathecal chemotherapy. In this study, we aim to evaluate the safety and effectiveness of patient using chemo-holiday therapy based on the cerebrospinal fluid cytology, combined with double-dose EGFR-targeted drug in patients with leptomeningeal metastases from EGFR-positive NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged between 18 and 75 years.

Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations.

Cytologically confirmed diagnosis of leptomeningeal metastasis.

Normal organ function.

Disqualifiers

Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.

Any evidence of extensive and lethal progressive systemic diseases without effective treatment.

Patients with poor compliance or other reasons that were unsuitable for this study

Trial design

Design model

Single group

Treatments tested in this trial

  • pemetrexed

    Drug

    The pemetrexed is administrated by intrathecal injection with a dose of 50mg, once per week for 4 weeks, followed by every four weeks thereafter. The cerebrospinal fluid(CSF) samples are collected every 4 weeks and the cytology examination will be performed. If CSF cytology was negative, CSF cytology was tested again 1 week later. Two negative tests were considered as negative CSF cytology. If the cytology of cerebrospinal fluid was negative after 4 consecutive intrathecal injections, the intrathecal injection should be stopped. If positive, continue to give a intrathecal injection every 4 weeks until CSF cytology is negative. If CSF cytological positivity or worsening of neurological symptoms occurs again during discontinuation, or if new symptoms appear, the intrathecal injection should be resumed every 4 weeks.

  • vometinib

    Drug

    double dose of vometinib (160mg)

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: intrathecal injection of pemetrexed and double dose of vometinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Overall survival is the time from the date of enrollment of this study to death due to any cause.

Time frame
From the enrollment of this study until date of death from any cause, up to a maximum of approximately 2 years

Secondary outcomes

1

Impact on quality of life

Impact on quality of life using QLQ-C30 (V3.0)

Time frame
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
2

Clinical response rate

The response assessment in neuro-oncology criteria (RANO) proposal for response criteria of leptomeningeal metastasis was used to assess the clinical response in this study.

Time frame
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
3

leptomeningeal metastases related progression-free survival

The neurological progression was determined based on the RANO proposal evaluation criteria which have been established and published on Neuro Oncol.

Time frame
From date of treatment until the date of first documented neurological progression or date of death from any cause, whichever came first, assessed up to 6 months.
4

CSF cytological clearance

The cerebrospinal fluid samples are collected every 4 weeks and the cytology examination will be performed.

Time frame
From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: