Aggressive Goals Fuel Research, Growth at 'The James'

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The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute opened on July 9, 1990, as the adult patient-care component of The Ohio State University (OSU) Comprehensive Cancer Center (CCC). Today, “The James,” as it is referred to, is the only dedicated cancer hospital in the Midwest. In addition, The James is one of 40 National Cancer Institute-designated comprehensive cancer centers in the United States and one of only five approved to conduct phase I and II clinical trials of new anticancer drugs.

Clinical Trials Bring Hope

Nearly 2 years ago, the cancer center outlined an ambitious goal to grow participation in clinical trials by 20% per year over a 28-month period, culminating with 2010 patients in therapeutic clinical trials by 2010. Thanks to a comprehensive strategy, the center accomplished this goal 5 months ahead of schedule.

“Most years before the campaign, we were averaging about 700 patients enrolled in therapeutic clinical trials,” James Thomas, MD, medical director of OSU ’s clinical trials office, explained. “For calendar year 2009, we’ll be around 1350 [patients] by the time the year is done—almost double over a 2-year time period.”

Thomas said The James’ success in clinical trial recruiting is attributable to a 3-pronged campaign aimed at increasing awareness and encouraging patient participation. The first step was placing patient-targeted marketing materials, including posters and pamphlets, in clinic areas to tout the benefits of clinical trial participation. The materials highlighted the results of multiple studies that show people who engage in cancer clinical trials receive better quality of care and experience better outcomes than those who pursue standard therapy.

The campaign then targeted physicians in Ohio and surrounding states who refer patients to the cancer center. The James alerted physicians by e-mail of new treatment trials and the availability of new agents. Going door to door internally at the OSUCCC also helped.

“We reminded everyone why we’re here,” Thomas said. “Cancer research is our focus; it’s our mission. We made sure everyone was aware of the mission and made certain we eliminated any barriers there might be for people enrolling in clinical trials.

“We often say we’re in the hope business,” said Thomas, explaining that clinical trials give patients hope by providing options to try to fight their cancer. While great strides have been made in the fight against cancer, Thomas acknowledged that there is a long way to go. Clinical trials, he said, will help pave that road.

“Nationally, we figure only about 3% of people with cancer go on clinical trials, so that’s the sad part,” Thomas said. “If we can increase participation in clinical trials, it’s going to help everyone because we’re going to continue to make progress.”

OSU’s Technology Pioneers

In 1999, OSU physicians were the first in the country to perform surgery using the da Vinci robotic surgical system. After starting with 1 or 2 surgical disciplines using robotics, OSU now has more than 25 surgeons from more than 8 specialties who are skilled in robotic-assisted surgery and are performing robotic-assisted procedures, including laparoscopic surgery for prostate cancer. The University has also established the Center for Advanced Robotic Surgery, representing the next evolution in surgical care.

Ronney Abaza, MD, codirector of the Center for Advanced Robotic Surgery, director of Robotic Urologic Surgery, and assistant professor of Urology at OSU, said the technology behind robotic instrumentation has phenomenally improved the performance of laparoscopic procedures. “We can now do even the most complex procedures in minimally invasive fashion because the robot allows us to do anything we could have done by hand through an open incision, but now through these tiny incisions,” Abaza explained. “Imagine that we’re doing the same operation on the inside without cutting any corners. But instead of doing it with our own hands, we’re doing it with tiny robotic hands the size of a pen.”

The benefits to patients are clear: less pain, less time in the hospital, and quicker recovery. Abaza said when it comes to evaluating whether an operation can be done robotically, the basic rule of thumb is that the expected quality must equal what could be accomplished by hand in an open surgical procedure. “The level of expectation we set for ourselves is that we won’t cut any corners just to be able to offer a minimally invasive operation,” he said.

The center’s surgeons perform approximately 1200 robotic surgeries annually. In addition, they train hundreds of other physicians and surgical teams on robotic techniques, many of which OSU surgeons pioneered. Abaza pointed out that the move from open surgery to robotic surgery is extremely challenging—like learning the entire operation anew. The majority of surgeons performing robotic surgery in the United States had to learn the new robotic techniques while maintaining an already busy practice, which slowed the learning curve.

“In addition to the challenge of learning [robotics], you have to have enough surgical volume to keep your skills up,” Abaza said. “It makes it very important for patients who are seeking out a robotic surgeon to find someone who is already very experienced.” Abaza added that it is important for teaching institutions like OSU to equip the next generation of surgeons with the necessary skills to perform quality robotic surgeries in the real world.

Abaza and his colleagues have begun delving into procedures that are “off the beaten path” to determine which might be best done robotically. “Robotic surgery is going to become more and more pervasive across surgical disciplines, and technology is going to continue to improve,” said Abaza. “That will combine with our imagination and allow us to do even the most complex procedures in even more minimally invasive fashion than we’re doing now.”

Looking Ahead with ProjectONE

The Center for Advanced Robotic Surgery is not the only department at OSU planning for tomorrow. The importance of being primed for the challenges ahead has not been lost on OSU CCC. Last September, OSU’s board of trustees approved plans for the construction of ProjectONE, an expansion project that will significantly advance the medical center’s education and research programs and improve care. The $1 billion investment will transform the OSU medical center’s central campus. It includes a centralized single-tower design that will house the new Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, along with a critical care building and integrated spaces for research, education, and patient care.

ProjectONE is said to be one of the largest job-generating initiatives in Ohio’s history, creating as many as 10,000 fulltime jobs and more than 5000 construction jobs. ProjectONE is expected to generate $1.7 billion annually for the community by 2015, which is in addition to the more than $4 billion generated annually by the university.

The James expects inpatient admissions to increase by 21% in the next 10 years. “As cancer is on pace to become the world’s No. 1 killer by next year, we see this expansion as a crucial step to provide the best treatments possible for patients who are seeking potentially life-saving therapies,” said Michael Caligiuri, MD , director of OSUCCC and CEO of The James. “ProjectONE is a necessary investment in the future of cancer care.” It is expected that the ProjectONE expansion will facilitate treatment of an additional 310,000 patients each year. New facilities are essential if the center is to continue to attract and retain leading doctors and scientists and compete for research funding from the National Institutes of Health and other sources, Caligiuri said.

The Finish Line

The goal for The James, Thomas said, is to gain recognition as one of the top 10 cancer centers in the country. To achieve this, the center must continue to expand in size and resources. “Obviously, building the new cancer hospital is a big part of that, and research is going to be at the core of that facility,” he said. “We want to continue to grow in both the quantity of research that we do and also the quality of research that we do.” At the heart of the center’s mission lies the same desire it has always had: to improve people’s lives through conducting innovative research, expanding educational opportunities, and providing exemplary patient care.

Ed Rabinowitz is a veteran healthcare journalist based in Bangor, Pennsylvania.

Clinical Trials

Several trials are underway at The Ohio State University (OSU) Comprehensive Cancer Center. For more information about the trials listed below, visit ClinicalTrials.gov and search using the trial ID number or contact the investigators.

Phase II: SCH 727965 for Relapsed/Refractory AML and ALL

This trial, sponsored by Schering-Plough, is accruing patients at several sites throughout the United States, including OSU. Alison Walker, MD, is leading the study at OSUCCC, which is looking at the overall response rate (ORR ) of AM L or ALL patients to initial treatment with SCH 727965. In addition, the study will evaluate the ORR of AML patients treated after disease progression on a comparator.

OSU ID: 08144

ClinicalTrials.gov ID: NCT00798213

Contact: SP Clinical Trial Registry Call Center, (888) 772-8734

Phase I/II: Elotuzumab Plus Bortezomib in Relapsed/Refractory MM

In this randomized open-label trial, sponsored by Facet Biotech, investigators are conducting a dose-escalation study of elotuzumab, a human monoclonal antibody, combined with bortezomib (Velcade). Multiple myeloma patients enrolled in the study must have progressive disease following 1 to 3 prior regimens. Don Benson, MD, PhD, is serving as principal investigator for the OSU study.

OSU ID: 09025

ClinicalTrials.gov ID: NCT00726869

Contact: OSU Clinical Trial Matching Service, (866) 627-7616 or osu@emergingmed.com

Phase I: ABT-888 with or without Mitomycin C in Unresectable Metastatic Solid Tumors

Inhibitors of poly ADP-ribose polymerase (PARP ) are known to sensitize cells to DNA damaging agents. In this study, led by Miguel A. Villalona-Calero, MD, patients will have their tumor tissue screened to determine whether they have functional defects in the Fanconi anemia pathway of their tumors and are more likely to benefit from the combination of a PARP inhibitor with mitomycin C.

OSU ID: 09100

ClinicalTrials.gov ID: NCT01017640

Contact: OSU Clinical Trial Matching Service, (866) 627-7616 or osu@emergingmed.com

Phase I: AR-12 in Advanced or Recurrent Solid Tumors or Lymphoma

Led by James Thomas, MD, this study of AR-12 is a first-in-man trial of an oral chemotherapy that is designed to inhibit the 3-phosphoinositide-dependent kinase-1. The study is sponsored by Arno Therapeutics and plans to accrue 50 patients for whom no standard therapy is available.

ClinicalTrials.gov ID: NCT00978523

Contact: Kristy Culler, (866) 627-7616 or osu@emergingmed.com