When traditional therapies fail, early stage clinical trials represent a new beacon of hope for patients with seemingly terminal cancers.
This winter, the UC College of Medicine launched a phase-1 clinical trials unit through the newly established Early Drug Development Program. Olivier Rixe, MD, PhD, professor of medicine in the hematology oncology di-vision at UC, serves as dir-ector of the program.
Phase-1 oncology trials are the first stage of testing a new drug or anticancer treatment in human subjects. This is where bench research translates to bedside. Studies take place in a highly targeted and small segment of the patient population—typically no more than 50 people—at highly experienced academic health centers. UC’s phase-1 therapy will be administered at UC Health University Hospital.
According to Rixe, who has spent more than 15 years conducting early stage drug development trials, less than 10 phase-1 clinical trials units are currently in operation in the United States. The UC center will be the first within 120 miles of Cincinnati to offer adult phase-1 clinical trials for cancer.
The Cincinnati Children’s Cancer and Blood Diseases Institute currently offers early stage clinical trials for pediatric cancers.
The Early Drug Development Program and phase-1 clinical trials unit is part of the Cincinnati Cancer Consortium, a joint cancer program involving the UC College of Medicine, Cincinnati Children’s Hospital Medical Center and University Hospital. The collaborative initiative brings together interdisciplinary research teams of caring scientists and health professionals to research and develop new cures, while providing a continuum of care for children, adults and families with cancer.
George Atweh, MD, director of the hematology oncology division at UC and the adult cancer program, says it was a major achievement for the adult cancer program when Rixe agreed to come to UC.
Rixe has spent more than two decades involved in early stage drug development trials that resulted in successful anti-tumor agents used today, including oxaliplatin, camptothecins and taxanes as well as targeted therapies, including compounds known as “anti-angiogenics” that block vessel growth in tumors, including sunitinib, axitinib and VEGF-trap.
“Dr. Rixe is an exceptional recruit who is uniquely qualified to build and lead a successful early stage drug development program for cancer at UC,” says Atweh. “His recruitment—and the institution’s investment in this phase-1 clinical trials unit—are strong steps toward building a comprehensive cancer research and treatment center for the Greater Cincinnati community.”
Because phase-1 and 2 clinical trials are considered experimental, they are typically only conducted at major academic health centers where there are both strong clinical oncology and basic research components in place. Centers must also have a dedicated hospital-based unit for administering care and a team of experienced support staff to monitor patients throughout treatment.
“Phase-1 trials are different than the clinical trials patients find at community-based practices. These earliest of stage trials are intended to evaluate safe dosages, method of administration (oral or injection) and frequency, so this is the first step between bench and bedside,” explains Rixe.
“Like all clinical research, phase-1 trials have exclusion criteria, but in general, all patients with solid cancerous tumors that have failed standard therapy can participate. Enrollment is not limited to patients with a certain type of cancer.”
At UC, phase-1 trials will focus on three primary areas: cytotoxic (cancer cell killing) drugs, potential molecular targets for new drugs and immunotherapy.
Rixe expects the program’s first phase-1 oncology trial to open for enrollment at the UC Barrett Cancer Institute at University Hospital this spring. The trial, which is pending Institutional Review Board approval and sponsored by Sanofi Aventis, will test a combination of two cytotoxic drugs for solid tumors that are thought to work with a different targeted mechanism of action to kill cancer on a cellular level.
Three additional phase-1 trials are expected to open this spring that will test targeted anti-cancer agents with a new mechanism of action.
To learn more about clinical trials at UC, call (513) 584-7698. For information on the benefits and risks of phase-1 clinical trials, visit www.cancer.gov/clinicaltrials.