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Ventriculo-lumbar perfusion chemotherapy for Leptomeningeal carcinomatosis

Methotrexate Ventriculo-lumbar perfusion chemotherapy for Leptomeningeal carcinomatosis: phase 2 study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0000082
Enrollment
56
Registered
2011-01-24
Start date
2011-01-21
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Medical Device, Procedure/Surgery : 1) Day 0: evaluation of leptomeningeal carcinomatosis (LMC) related symptoms 2) Lumbar drainage is installed 2 hours before VLP to confirm constant CSF flow.
IV fluids, tube feedings, or TPN indicated =24 hrs Confusion Confusion or delirium interfering with ADL Disorientation to person Seizure Sz's in which consciousness is altered
poorly controlled sz, with breakthrough generalized sz's despite medical intervention One brief generalized Sz? grade 2 *Encephalopathy Signs or symptoms interfering with ADL
hospitalization indicated Altered mentality *Symptoms of MTX-related encephalopathy are delirium, agitation, incoherent speech, tremor, nystagmus, seizure, etc

Sponsors

National Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) diagnosis of leptomeningeal carcinomatosis (LMC) by either CSF cytology or definite MR findings 2) at least one symptom of LMC; headache or increased intracranial pressure (> 15cm H2o), hydrocephalus, cranial neuropathy or cauda equine symptoms 3) patient agree to the experimental protocol

Exclusion criteria

Exclusion criteria: 1) CSF pathway block on wholspine MRI or RI cisternography, 2) Brain space occupying lesion, which could possibly cause herniation 3) Hemorrhagic brain metastasis 4) More than grade 3 leucopenia (ANC < 1,000) or thrombocytopenia (< 50K) 5) Altered mentality as severe as verbal communication is not possible 6) Active systemic cancer progression, at which expected survival is less than 2 months.

Design outcomes

Primary

MeasureTime frame
Cauda Equina symptoms;intracranial pressure ;altered mentality;Cranial neuropathy

Secondary

MeasureTime frame
CSF MTX level;serum MTX level;CSF cytology;Carcinoembryonic antige (CEA)

Countries

Korea, Republic of

Contacts

Public ContactHo-shin Gwak

National Cancer Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026