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Convection enhanced delivery using ACNU and oral temozolomide therapy to treat recurrent spinal anstrocytoma

Convection enhanced delivery using ACNU and oral temozolomide therapy to treat recurrent spinal anstrocytoma - ACNU CED for recurrent spinal astrocytoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015001
Enrollment
15
Registered
2014-09-01
Start date
2011-09-09
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

spinal cord astrocytoma

Interventions

Catheter implantation (day1) ACNU (0.25 mg/ml or lower)+ Gd-DOTA(1mM) infusion (day1-2) and TMZ (200mg/m2) p.o. (day1-5)

Sponsors

Tohoku University, Graduate school of medicine, Department of Neurosurgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) For those who suffer recurrent spinal cord astrocytoma and surgical treatment is not indicated. Cases include spinal cord originated tumors and disseminated lesion from intracranial astrocytoma. 2) For those who suffered recurrence after standard treatments including surgical removal, radiotherapy and chemotherapy. 3) For those who did not undertake any of the above mentioned treatment during the previous 4 weeks. 4) For those who have normal laboratory checkup. 5) For those who gave consent to be included in the exam.

Exclusion criteria

Exclusion criteria: 1) For those suffering other cancer 2) For those suffering meningitis or pneumonia 3) Pregnant or Lactating women 4) For those suffering inflammation 5) For those suffering liver dysfunction 6) For those suffering myelo -suppression 7) For those suffering kidney dysfunction 8) For those having bleeding tendency or undertaking anti-coagulation or anti-platelet therapy 9) For those suffering psychiatric disorder 10) For those suffering uncontrolled Diabetes mellius 11) For those who have history of cardiac infarction in the last three months, or suffering angina pectoralis 12) For those having history of Idiopathic pulmonary fibrosis or interstitial pneumonia

Design outcomes

Primary

MeasureTime frame
Determine maximum tolerable concentration of ACNU

Secondary

MeasureTime frame
Effectiveness, survival rate of 6 months, and overall survival

Countries

Japan

Contacts

Public ContactToshiki Endo

Tohoku University Graduate School of Medicine Neurosurgery

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

Outcome results

None listed

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