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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011538

Enrollment

Registered

2013-08-20

Start date

2013-08-20

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

malignant glioma

Interventions

First 3 cases receive convection- enhanced delivery of 20ml solution (volume is fixed to 20 ml throughout the study) of 0.25 mg/ml nimustine hydrochloride (mixed with 5mM Gd-DOTA: this concentration w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) First recurred operable malignant glioma cases in patients who already received initial treatment with histological diagnosis of malignant glioma . 2) Recurrent cases after treatment with standard regimen; radiation plus oral temozolomide for grade IV or radiation plus intravenous ACNU for grade III. 3) Histological diagnosis of recurrent tumor from surgery performed within two weeks from initiation of CED of ACNU. 4) Appropriate systemic condition: WBC (>3,000/mm3), Hb (>8.0 g/dl), Plt (>10x104/mm3), GOT (<100 IU/l), GPT (<100 IU/l), Cre (<1.5 mg/dl) should be cleared (within 14days of study initiation) 5) 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 approval.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Phase I: Determination of maximum tolerable concentration of ACNU Phase II: 6 months progression free survival rate	—

Secondary

Measure	Time frame
Progression free survival, Overall survival	—

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