Convection enhanced delivery to treat malignant recurrent spinal cord astrocytoma

Phase 1

Recruiting

• Conditions: Spinal cord tumor; Recurrent malignant spinal cord astrocytoma

• Registration Number: JPRN-jRCTs021180010
• Lead Sponsor: Tominaga Teiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year overall survival rate

Secondary Outcome Measures

Name	Time	Method
1) Overall survival (OS) <br>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. <br>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%<br>4) Adverse event occurrence rate