Recurrent malignant spinal cord astrocytoma Spinal cord tumor
Conditions
Interventions
ACNU delivery (0.25 mg/ml, 4ml) into the spinal cord by CED method
Temozolomide (200mg/m2/day) oral intake for 5 days
Sponsors
Endo Toshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically considered a spinal cord recurrent glioma. Radiographically, it is an intramedullary lesion, and originated from it. Spinal recurrent disseminated lesions of intracranial primary malignant gliomas such as cerebrum, cerebellum, brain stem (these cases need to have tissue diagnosis of the primary tumor) are targeted.
Exclusion criteria
Exclusion criteria: 1) have active duplicate cancer 2) Merging of meningitis or pneumonia requiring treatment 3) During pregnancy, women with the potential for pregnancy or breast-feeding 4) Active inflammatory findings exist (CRP> 2.0) 5) Severe liver dysfunction exists (GOT> 100 IU / l or GPT> 100 IU / l) 6) Leukocytes (3000 / mm3) in which bone marrow dysfunction exists, Hemoglobin (8.0 g / dl), Platelets (10 x 10 4/mm3) 7) Creatinine with renal failure (> 1.5 mg / dl) 8) have bleeding diathesis 9) Oral administration of anticoagulant or antiplatelet drug 10) Psychosis or psychiatric symptoms are merged and it is judged difficult to participate in the exam 11) Merging diabetes with poor control 12) have a history of myocardial infarction within 3 months or have unstable angina 13) have a history of pulmonary fibrosis or interstitial pneumonia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerable concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival (OS) 2) Response Ratio (Response Efficiency) The percentage of patients whose effect on target lesion is judged to be either Complete Remission or Partial Response shall be the response rate. 3) Determination of tumor shrinkage effect Definition of the measurement lesion Measurement of the lesion is performed by MRI of a slice of 8 mm or less. Long diameter tumor reduction ratio = (long diameter before treatment - long diameter at evaluation) / long diameter before treatment x 100% Increase rate of long diameter = (major axis at evaluation - minor long diameter) / minor major diameter x 100% 4) Adverse event occurrence rate | — |
Contacts
Public ContactToshiki Endo
Tohoku Medical and Pharmaceutical University Hospital
Outcome results
None listed