An observational study in Leptomeningeal Metastasis and Lung Cancer, sponsored by Xiangya Hospital of Central South University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Xiangya Hospital of Central South University · Observational
This is a open-label, multi-center prospective observation study for the efficacy and safety of intraventricle pemetrexed disodium via ommaya reservoir in the treatment of leptomeningeal metastasis with lung cancer who have failed at least one targeted therapy. In detail: At least the treatment failure was after third-generation EGFR-TKIs in EGFR-mutated lung cancer; or at least the treatment failure was after second-generation ALK-TKIs in ALK-mutated lung cancer; or at least the treatment failure was after one-line of targeted-TKIs in ROS1-mutated non-squamous non-small lung cancer.
Participants were randomizedly assigned in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 2 weeks,or in cohort 2 will be given pemetrexed 30mg once a week.
It was designed for two stages on treatment course. Induction therapy: Efficacy evaluation every 2 cycles, and confirm the efficacy at the next cycle. If at the next cycle, the efficacy result changed (such as SD or PR after initial PD; or PD after initial SD or PR; the second time of efficacy assess was required）. If the CSF cytology at the time of the efficacy evaluation was negative, one more cycle was required to confirm the CSF cytology.
Consolidation: If the efficacy is remission(including complete remission, obvious remission, or partial remission) or stable disease for initial timepoint and the timepoint of the confirmed evaluation; then the patient will be advanced to the stage of consolidation treatment. Participants in cohort 1 who will be given pemetrexed 20mg every 24 hours for 72 hours every 3 weeks. Participants in cohort 2 will be given pemetrexed 30mg every 3 weeks. Until the toxicity is intolerable, or disease progression.
Cross over： Compared the first 4 enrolled cases in each group; the comprehensive evaluation(including efficacy, cytology negative, toxicity) in better group(50% higher efficacy or 50% less toxicity) will be the following cohort, to which the other one will crossover.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 64 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Xiangya Hospital of Central South University is the lead sponsor of 170 studies on the registry; 76 are open to participants now.
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non-squamous non-small cell lung cancer with oncogene-driven and failed at least one-line of targeted therepy ( EGFR/ALK/ROS1); At least failure after third-generation EGFR-TKIs in EGFR-mutated lung cancer. At least failure after second-generation ALK-TKIs in ALK-mutated lung cancer. At least failure after one line of targeted-TKIs in ROS1-mutated non-squamous non-small lung cancer.
In accordance with the CSCO Guidelines for the Diagnosis and Management of Central Nervous System Tumors, and the EANO-ESMO diagnostic criteria: a diagnosis of type I meningeal metastatic carcinoma is made when cerebrospinal fluid cytology testing reveals anisocytosis (3 consecutive tests are required if the cerebrospinal fluid cytology testing is initially negative for the patient) (one study showed that the specificity of anisocytosis in diagnosing meningeal metastases in patients with solid tumors was 100%) or meningeal lesions Biopsy confirms the diagnosis. (Type IIA-C meningeal metastases: negative or atypical cerebrospinal fluid cytology, MRI showing linear or/and nodular meningeal enhancement\^ with typical clinical symptoms*).
MRI: at least 1.5T; demonstrates sulcal, smear, or linear ventricular enhancement, cranial nerve root enhancement or nodular meningeal enhancement, or cauda equina spinal enhancement; control enhancement T1-weighted sequences and Flair sequences; nodularity is defined as foci of ≥ 5x10mm enhancement; sequences of choice: cranial planar enhancement + T2Flair (enhancement) or and total spinal planar enhancement (when suspicion of spinal involvement); 3D T1 enhancement (involved cranial nerves - optional); cerebrospinal fluid flow imaging (functional or anatomic).
Typical clinical manifestations: headache, nausea, vomiting; epilepsy; mental changes, gait difficulties; cranial nerve damage (diplopia, visual abnormalities, hearing abnormalities, facial nerve palsy, difficulty chewing, difficulty swallowing, choking, etc.); neurogenic signs (cauda equina symptoms, mainly perineal numbness, tingling, defecation and urination disturbances, weakness or incomplete paralysis of both lower limbs); sensorimotor defects of the limbs; cervical back Radicular pain; be careful to differentiate from signs and symptoms of brain parenchymal metastases, extracranial disease, treatment-related adverse effects, and non-tumor comorbidities.
Exclusion Criteria:
Pemetrexed 20mg every 24 hours for 72 hours every 2 weeks until efficacy evaluated remission or stable ; change to every 3 weeks.
Drug: Pemetrexed injection · Drug: Pemetrexed
Pemetrexed 30mg D1 every week until efficacy evaluated remission or stable ; change to every 3 weeks.
Drug: Pemetrexed injection · Drug: Pemetrexed
Group 1（20mg）:induction stage is 20 mg per 24 hours for 72 hours, every 2 weeks; consolidation stage is 20mg per 24 hours for 72 hours, every 3 weeks.
Also known as: Alimta
Group 2（30mg）:induction stage is 30 mg D1，every week.Consolidation stage is 30 mg D1,every 3 weeks.
Also known as: Alimta
Objective response rate，ORR
ORR is the ratio of the patients who achieve the complete remission(CR), obvious remission(OR), or partial remission(PR) to the included patients eligible for efficacy assessment. complete remission(one of the following items): normal RANO；normal Glasgow Coma Scale；KPS≥90. obvious remission(one of the following items): the improvement of at least 70% items on the RNAO examinations; Glasgow Coma Scale≥12 or at lease 3 scores increase compared to baseline; KPS≥70 or at lease 30 scores increase compared to baseline. partial remission(one of the following items)：the improvement of at least 50% items on the RNAO examinations; Glasgow Coma Scale≥9 or at lease 2 scores increase compared to baseline; KPS 50-70 or at lease 20 scores increase compared to baseline.
Time frame: 3 months
Disease control rate,DCR
DCR is the ratio of the patients who achieve the CR, OR, PR,or SD to the included patients eligible for efficacy assessment. complete remission(one of the following items): normal RANO；normal Glasgow Coma Scale；KPS≥90. obvious remission(one of the following items): the improvement of at least 70% items on the RNAO examinations; Glasgow Coma Scale≥12 or at lease 3 scores increase compared to baseline; KPS≥70 or at lease 30 scores increase compared to baseline. partial remission(one of the following items)：the improvement of at least 50% items on the RNAO examinations; Glasgow Coma Scale≥9 or at lease 2 scores increase compared to baseline; KPS 50-70 or at lease 20 scores increase compared to baseline. stable disease (one of the following items ):the improved items on the RNAO examinations less than 50%; the change of Glasgow Coma Scale within 1 score compared to baseline; the change of KPS within 10 scores.
Time frame: 2 years
progression-free survival，PFS
time to the progression of disease. Progression of disease(one of the following items): The deterioration of at least 25% items on the RNAO examinations; the drop of Glasgow Coma Scale more than 1 score compared to baseline; the drop of KPS score more than 10 scores.
Time frame: 2 years
overall survival,OS
time to the death or loss of follow-up
Time frame: 2 years
CSF cytology clearance
negative results using glass slide centrifugation accompanied with staining
Time frame: 2 years
Adverse effect（AE） and severe Adverse effect(SAE)
number of participants with treatment-related adverse events or severe adverse effect as assessed by CTCAE 5.0
Time frame: 2 years
Plan to share: Undecided — we will share the some dates to the website:http://www.medresman.org.cn/login.aspx or publication of results of clinical trials in the form of papers
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Xiangya Hospital of Central South University