The Principal Investigator is Dr. Miguel Villalona-Calero, Professor, Division of Hematology/Oncology and Department of Internal Medicine and Pharmacology at The Ohio State University Comprehensive Cancer Center. "We are quite excited about this trial, since there are no known therapies that to date have effectively targeted K-RAS in cancer patients," said Dr. Villalona-Calero. "If this therapy works, this could substantially impact the outlook for our patients."
This trial (REO 016) is a single arm, single-stage, open-label, Phase 2 study of Reolysin given intravenously with paclitaxel and carboplatin every 3 weeks. Patients will receive four to six cycles of paclitaxel and carboplatin in conjunction with Reolysin, at which time Reolysin may be continued as a monotherapy. It is anticipated that up to 36 patients will be treated in this trial.
Eligible patients include those with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, who have not received chemotherapy treatment for their metastatic or recurrent disease. Patients must have demonstrated mutations in K-RAS or EGFR, or EGFR gene amplification in their tumours (metastatic or primary) in order to qualify for the trial.
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Dr. Einstein and his colleagues found that study participants had key differences at two locations in their TAP genes. Those women who possessed one or the other of these two gene variants were less than half as likely as other women to have developed high-grade CIN. Even women infected with the HPV types most likely to lead to cervical cancer were afforded protection by these variants. The finding suggests that knowledge of these genetic variants, known as polymorphisms, can provide important information regarding protection against cervical cancer.
"We're hopeful that our findings will lead to a genetic test that will help us predict which patients with persistent HPV infection are most likely to develop high-grade CIN and, ultimately, cervical cancer," says Dr. Einstein. "That knowledge should help us in mapping out effective treatment plans that are tailored to the individual patient. This trend of personalized medicine is becoming more common as new technologies offer hope of better tests."
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