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Convection-enhanced delivery of Nimustine Hydrochloride combined with oral temozolomide against recurrent malignant gliomas

Convection-enhanced delivery of Nimustine Hydrochloride combined with oral temozolomide against recurrent malignant gliomas - CED of ACNU combined with oral TMZ against recurrent malignant gliomas

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003983
Enrollment
10
Registered
2010-08-03
Start date
2010-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent malignant glioma

Interventions

Convection-enhanced delivery of ACNU

Sponsors

Department of Neurosurgery, Tohoku University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathological diagnosis of recurrent malignant glioma. In case of brainstem gliomas, clinical diagnosis of diffuse brain stem glioma or malignant glioma should be sufficient. 2) Recurrent cases after standard therapy. 3) Inoperable cases or cases that refused surgical resection. 4) No treatment within 4 weeks before this study. 5) 6 years old or elder. 6) No systemic complication. 7) Informed consent is required.

Exclusion criteria

Exclusion criteria: 1) Cases suffering active cancer 2) Cases suffering meningitis or pneumonia 3) Pregnant or breast feeding woman 4) Karnofsky performance status score less than 30 5) Cases suffering active inflammation 6) Cases with severe liver dysfunction 7) Cases with bone marrow insufficiency 8) Cases with renal failure 9) Cases with hemorrhagic diathesis 10) Cases taking anti-coagulative or anti-platelet agents 11) Cases with psychological diseases 12) Cases with uncontrolled Diabetes Mellitus 13) Cases suffered myocardial infarction within 3 months or cases with unstable angina 14) Cases that have history of pulmonary fibrosis or interstitial pneumoniae

Design outcomes

Primary

MeasureTime frame
Toxicity Response of targeted lesion

Secondary

MeasureTime frame
Best overall response

Countries

Japan

Contacts

Public ContactRyuta Saito

Tohoku University Graduate School of Medicine Department of Neurosurgery

ryuta@nsg.med.tohoku.ac.jp022-717-7230

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026