Efficacy of 15 cc/hr perfusion rate in Ventricular-Lumbar Perfusuion therapy for letomenigeal carcinomatosis; phase 2 study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0001222

Enrollment

Registered

2014-09-15

Start date

2014-05-09

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 : Treatment Plan : 1) Day 0: We evaluate patient’s symptoms related to leptomeningeal carcinomatosis(LMC). 2) Lumbar drainage is carried out 2 hours before intraventricular infusion for const

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. proven CSF cytology (if clinically suspicious, repeat 3 times of CSF cytology at least 1 week interval before clarifying it negative) 2. at least one symptom of LM seeding: - hydrocephalus or L-puncture pressure > 20 cm H2O - cranial neuropathy other than mass symptom - L/E pain or weakness other than mass symptom 3. Patient & family agree to the protocol

Exclusion criteria

Exclusion criteria: 1. CSF pathway block on either wholespine MRI or RI cisternography. 2. Brain space-occupying lesion, which could possibly cause herniation. 3. Hemorrhagic metastases 4. Grade 3 leucopenia (WBC < 2,000 or ANC < 1000/mm3) or thrombocytopenia (< 50 K) patient 5. have VLP chemotherapy before

Design outcomes

Primary

Measure	Time frame
To evaluate the clinical response rate of ventriculolumbar perfusion (VLP) chemotherapy with methotrexate (MTX) on leptomeningeal carcinomatosis (LMC)	—

Secondary

Measure	Time frame
To evaluate the side effect of ventriculolumbar perfusion (VLP) chemotherapy with methotrexate (MTX) on leptomeningeal carcinomatosis (LMC)	—

Countries

Korea, Republic of

Contacts

Public ContactJi Hye Lee

NCC Hospital

Outcome results