The experimental vaccine targets two specific regions of the human epidermal growth factor receptor 2 (HER-2), a molecule that occurs in abnormally high levels in up to 30 percent of breast cancers. Another component of the vaccine targets HER-1 (EGFR) a molecule that is overexpressed in many other solid tumors, including ovarian, renal, colon, lung, and gastro-intestinal cancers, says researcher Pravin Kaumaya, PhD, professor and director of the vaccine research division in the Department of Obstetrics and Gynecology. Kaumaya led the development of the protocol for this NCI funded trial, as well as development of the vaccine.
The goals of the phase I trial include determining the safety and optimal dose of the HER-2 vaccine; evaluating whether the vaccine shows therapeutic benefit by stimulating the immune system to respond to the patient’s tumor; and documenting any clinical responses that may occur. In addition, Kaumaya says, this phase I study includes an innovative efficacy arm that was approved by the Food and Drug Administration, which must okay all clinical trials conducted in the United States.
Study participants must be 18 years of age or older and have a metastatic solid tumor that is considered incurable using standard treatment. Patients with tumors that do not express the HER-2 molecule may also be eligible to participate.
For further information about enrolling in the study, please call the OSUCCC – James at 1-800-293-5066.
The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (http://cancer.osu.edu) is one of only 40 Comprehensive Cancer Centers in the United States designated by the National Cancer Institute. Ranked by U.S. News & World Report among the top cancer hospitals in the nation, The James is the 205-bed adult patient-care component of the cancer program at The Ohio State University. The OSUCCC-James is one of only seven funded programs in the country approved by the NCI to conduct both Phase I and Phase II clinical trials.