The UCSF clinical trial is a phase1/2 study designed to establish the feasibility, safety and preliminary efficacy of vaccination in patients with recurrent, high-grade glioma. The trial involves two groups of six patients, both of which receive a minimum of four injections: the first group receives biweekly vaccinations and the second receives weekly vaccinations. Patients are monitored for immune response before, during and after treatment.
In the first group, study results showed tumor-specific immune response was detected after vaccination in all six patients. Researchers observed that patients whose disease was stable after surgical resection and before vaccination were more likely to respond clinically. Of the first six patients treated, five have exceeded the historical median benchmark of 6.5 months survival from time of recurrence. All six have exceeded the overall survival historical benchmark of 14.6 months from time of diagnosis.
The UCSF investigators will continue to follow patients for progression-free survival and overall survival. According to investigators, no adverse events or toxicity identified were considered attributable to the vaccine. Based on these preliminary findings, a larger phase 2 study is planned for 2007.
Rosalind Hekkala, a 66-year-old woman from Reno, Nev., who was enrolled in the first study group, was originally diagnosed with a brain tumor in July 2005. She had surgery to remove it, but the tumor returned in November. Her daughter learned of the trial at UCSF and Hekkala enrolled. In January 2006 she had another surger
Source:University of California - San Francisco