After the successful and promising completion of the Phase I feasibility study regarding glioblastoma multiforme (malignant brain tumor), clinical testing of the new nano-cancer therapy was begun in a Phase II clinical trial. In accordance with the medical products act, this efficacy trial includes patients with recurrence of glioblastoma multiforme (WHO stage IV).

Study title

Reintervention in recurrences of glioblastomas using thermoradiotherapy with magnetic nanoparticles ("magnetic fluid hyperthermia", MFH)

Principal investigator

Prof. Dr. med. Klaus Maier-Hauff

Study start

March 2005

Inclusion criteria

• Patients with relapse of glioblastoma multiforme after primary treatment
  
• Age: 18 to 75 years old, estimated life expectancy > 3 months
• Karnofsky Index > 60%
• Supratentorial and unifocal localization
  
• Maximum extent of the tumor: 6 cm
• No metal in the skull, facial skull or brain (aside from clips)
• No tumorous infiltration of the contralateral side
• No growth of the tumor into the brain stem
  
• No pregnancy
• No cardiac pacemaker or defibrillator
• No participation in other studies
• Patient’s declaration of consent

CLOSED: Feasibility trial (Phase I) regarding the use of nano-cancer therapy in GLIOBLASTOMA MULTIFORME

From March 2003 to July 2004, the first clinical study worldwide on the feasibility of thermotherapy with magnetic nanoparticles was carried out on 14 glioblastoma multiforme patients. The results demonstrated the clinical feasibility of the new procedure, its excellent tolerability, and the attainability of temperatures between 43°C / 110°F and more than 50°C / 122°F in deep-seated tumor areas of the brain. The application of the magnetic fluid and the subsequent thermotherapy was very well tolerated by all patients. Even though this was a feasibility study, clear signs of local effectiveness of the therapy were recognizable.