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Lókoregionale Tiefenhyperthermie begleitend zu ACNU in der Rezidivtherapie von Patienten mit malignen Gliomen (WHO°III/IV)- Phase I/II-Studie - Hypergliom

Lókoregionale Tiefenhyperthermie begleitend zu ACNU in der Rezidivtherapie von Patienten mit malignen Gliomen (WHO°III/IV)- Phase I/II-Studie - Hypergliom

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002180-90-DE
Enrollment
Unknown
Registered
2006-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Recurrent malignant glioma

Interventions

Product Name: ACNU Product Code: Nimustinhydrochlorid Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Nimustinhydrochlorid Other descriptive name: ACNU Concentration unit: mg/m2 milligr

Sponsors

Neurologische Uniklinik Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologie Gliom WHO° III/IV Alter 70% abgeschlossene Primärtherapie Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: mulitlokulärer Tumor Primärtherapie mit Nitrosoharnstoff Schrittmacher

Design outcomes

Primary

MeasureTime frame
Main Objective: Ermittlung der MTD bzw. DLT unter Gabe von ACNU in stabiler Dosierung und Behandlung mit regionaler Tiefenhyperthermie in eskalierter Frequenz, Anteil der Patienten mit PFS 6/12;Secondary Objective: mTTP, mOS, Ansprechrate, Nebenwirkungsprofil der Kombination, kognitive Leistungsfähigkeit;Primary end point(s): Ansprechen (nach McDonald) Abbruch bei Progress—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026