FDAnews
www.fdanews.com/articles/83360-researchers-confirm-effectiveness-of-gleevec-plus-hydroxyurea

RESEARCHERS CONFIRM EFFECTIVENESS OF GLEEVEC PLUS HYDROXYUREA

December 22, 2005

Researchers from the University of Pittsburgh, Duke University, and Dulman, Germany, have reported that the combination of Gleevec (imatinib mesylate) plus hydroxyurea provides benefit for approximately one-half of patients with recurrent glioblastoma multiforme. The details of this Phase II study were published in the Journal of Clinical Oncology.

The trial included 33 patients with recurrent glioblastoma multiforme that was progressing prior to initiation of the trial. They had had received prior treatment with radiation therapy and Temoda (temozolomide)-based chemotherapy. At six months, 27 percent of patients remained progression-free. Forty-two percent of patients achieved disease stabilization. Nine percent of patients had a partial regression of their cancer as seen on scans. The most common side-effects were low levels of white blood cells, low levels of platelets, and swelling. There were no severe side-effects.