Phase II multicenter investigator initiated trial of Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas - Convection-enhanced delivery of Nimustine Hydrochloride against brainstem gliomas

Tominaga Teiji0 sites30 target enrollmentJune 26, 2019

Overview

No summary available.

Registry

who.int

Start Date

June 26, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Tominaga Teiji

•1\) MRI had to demonstrate that at least two\-thirds of the tumor was situated in the pons and that the origin of the tumor was clearly within the pons.
•2\) Initially diagnosed patients with 3\-21 years of age.
•3\) 28\-35 days interval from prior radiation and/or chemotherapy. 56 days interval may be allowed for patients who got re\-registered to the study.
•4\) Patients received no prior anti\-tumor treatment except radiation and temozolomide chemotherapy.
•5\) KPS\>\=50 at screening.
•6\) Patients expected to be alive for more than 2 months.
•7\) Appropriate systemic condition: WBC(\>\=3,000/mm3\), Hb(\>\=8\.0 g/dl), Plt(\>\=100000/mm3\), AST(\<\=100 IU/l), ALT(\<\=100 IU/l), Cre(\<\=1\.5 mg/dl) should be cleared.
•8\) Informed consent taken from the patient. In case it is difficult to get the signature of patient due to neurological deficits, representative person may sign as long as patient is able to understand and give his or her approval.
•Initially diagnosed adult patients who fulfill \#1, 3, 4, 5, 6, 7, 8 of the pediatric criteria. Recurrent adult patients who fulfill below mentioned \#9 and 10 in addition to \#1, 5, 6, 7, 8 of the pediatric criteria.
•9\) Patients with tumor enlargement or symptom deterioration after standard radiation therapy.

•1\) Co\-existence of uncured cancer.
•2\) Patients with brain / spinal cord dissemination.
•3\) Women in pregnancy or possibly pregnant women or breast feeding women.
•4\) Patients who cannot take appropriate methods for contraception.
•5\) Infected patients who require systemic antibacterial or antiviral therapy.
•6\) Patients with hemorrhagic diathesis.
•7\) Patients taking anti\-coagulants or anti\-platelet agents within 21 days before clinical trials registry.
•8\) HBs antigen\-positive patients.
•9\) Existence of mental disorder that makes participation to this study difficult.
•10\) Poor control of diabetes mellitus.