Convection-enhanced delivery of Nimustine Hydrochloride combined with oral Temozolomide after surgical resection of recurrent malignant gliomas at first recurrence / Phase I/II study

Phase 1

• Conditions: malignant glioma

• Registration Number: JPRN-UMIN000011538
• Lead Sponsor: Department of Neurosurgery, Tohoku University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1) Co-existence of uncured cancer. 2) Co-existence of meningitis or pneumonia that require treatment. 3) Women in pregnancy or possibly pregnant women or breast feeding women 4) Severe liver dysfunction (GOT>100 IU/l or GPT>100 IU/l) 5) Existence of bone marrow insufficiency: WBC(<2,000/mm3), Hb (<8.0 g/dl), Plt(<10x104/mm3) 6) Renal dysfunction: Cre (>1.5 mg/dl) 7) Existence of hemorrhagic diathesis 8) Patients taking anti-coagulants or anti-platelet agents. 9) Existence of mental disorder that makes participation to this study difficult. 10) Poor control of diabetes mellitus 11) Past history of acute myocardial infarction within 3 months or unstable angina. 12) Past history of pulmonary fibrosis or interstitial pneumoniae.

Study & Design

• Study Type: Interventional
• Study Design: Not specified