Nanotech 2010

Thermotherapy using magnetic nanoparticles: increased median survival time following tumor recurrence in glioblastoma multiforme patients

A. Jordan, K. Maier-Hauff, H. Niehoff, F. Ulrich
MagForce Nanotechnologies AG, DE

Keywords: magnetic particles, clinical, glioblastoma

Abstract:

Here we present the outcome of a phase II pivotal glioblastoma study using a new nanomedical approach called Nano-Cancer® therapy. It consists of three components: an aqueous dispersion of iron oxide nanoparticles (NanoTherm®), a planning software (NanoPlan®) and an alternating magnetic field applicator (MFH®-300F). The particles are directly injected into the tumor region by a conventional stereotactic intervention. The Phase II study starting in 2005 was completed in November 2009 and is a single-arm clinical trial on the efficacy of the therapy. The 59 patients evaluated to determine the clinical efficacy of treatment with Nano-Cancer® therapy with accompanying radiotherapy attained a median survival time following diagnosis of the first tumor recurrence of 13.4 months (99% confidence interval: 10.6-16.2 months). Compared to the 6.2-month median survival time following recurrence observed in a recently published EORTC study with a total of 573 patients, the survival time with Nano-Cancer® therapy is statistically highly significant longer (p < 0.01). According to the experiences gained in these clinical trials, our Nano-Cancer therapy can be safely applied. The heat treatments were tolerated well without or with only minor side effects depending on the tumor location. Encouraging results were obtained in the treatment of advanced cancer patients.
 
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