Cancer Phase I Trials Enhance Knowledge and Expand Hope

Phase I Clinical Trial StaffMADISON - Delve into the foundation of the University of Wisconsin Paul P. Carbone Comprehensive Cancer Center's rich tradition of breakthrough clinical research in cancer therapy, and you unearth this intriguing possibility: Bright and talented as they are, the real genius of UW Carbone Cancer Center researchers may be their deep involvement in initial patient tests of new cancer treatments called Phase I clinical trials.
 
Phase I Trials a First Step

As the first step in a rigorous and systematic review process, Phase I trials have three objectives:evaluate the safety of a new drug or therapy, determine a safe dosage range and identify side effects, according to Carbone Cancer Center Assistant Director and Phase I Administrator Dona Alberti, BSN, RN. Planning and executing these trials can be a challenge, but Phase I research expands clinical knowledge, helps advance treatment alternatives and creates a climate that attracts and retains experienced researchers.

What's more, involvement in Phase I trials allow Carbone Cancer Center physicians to offer the latest investigational therapies to more than 200 people with advanced cancer every year, Alberti says. Her staff of 14 research specialists and nurses generally have 40 trials open to patients – and six-to-eight more trials in development. Yet this busy program is only one component of the larger Carbone Cancer Center clinical research program. The Cancer Center each years offers approximately 300 treatment trials, including Phase I trials, Phase II trials assessing outcomes and side effects of therapies that met Phase I muster and Phase III trials comparing patient outcomes of new and existing therapies.

Three Decades of Study
 
The participation of hundreds of patients, across three decades, has helped Carbone Cancer Center researchers move several therapies from Phase I studies into standard practice, including well-known agents such as interferon, interleukin, 5-fluorouracil (or "5-FU"), tamoxifen and taxol. Carbone Cancer Center trials have also contributed to adoption of innovations such as tomotherapy, stereotactic radiosurgery, high-dose-rate radiation therapy and multi-agent chemotherapy. And, recently, Carbone Cancer Center has facilitated several of the world's first Phase I "chemoprevention trials," evaluating the potential to inhibit the development of cancer. 

Meeting the high standards of federal, state and institutional requirements is no small feat, for Phase I trials are equal parts demanding and fruitful. They are only open to patients with advanced-stage cancer that is not responding to standard therapy, and they test unproven agents. Those two facts trigger extensive institutional and governmental oversight and intense monitoring of every patient, Alberti says. However, it is working with the patients and the patients' families that provide the greatest reward for doing early drug development.

Committed to a High Quality Comprehensive Program
 
The robust Phase I program of 2008 is a far cry from the one that existed in 1984 – when the late Paul P. Carbone, MD, doubled his staff by asking Alberti to be the program's first nurse. Momentum grew when medical oncologist and current Center Director George Wilding, MD, joined the program a few years later. It's no coincidence that two center directors have had hands-on roles in phase I trials, Alberti says.
 
"The Cancer Center leadership has always been committed to a high quality, comprehensive Phase I program," Alberti says.
 
That explains how she built a team that has, on an average, eight years of Phase I experience and 10-to-15 years of oncology experience, along with an annual operating budget approaching one million dollars.
 
Having such a seasoned team, and operating one of the country's busiest sites for investigational studies, makes the Carbone Cancer Center Phase I group a much-sought resource for federal agencies or pharmaceutical companies who are looking for a partner or administrator for an investigational study. The Carbone Cancer Center Phase I program conducts 12-to-15 pharmaceutical studies and 12 federal clinical trials per year. With so much experience, the UW team is able to implement a trial in a pace-setting two months.

The Invaluable Contributions of Patients
 
One investigator, Carbone Cancer Center medical oncologist Howard Bailey, MD, first heard the words "Phase I trial" as a medical school student talking with employees of a pharmaceutical company. During his two decades at the Carbone Cancer Center, Bailey has led or assisted in 40 Phase I trials.

As Carbone Cancer Center Associate Director for Clinical Research, Bailey has seen agents such as 5-FU and taxol become the focus of multiple Phase I trials, as they are evaluated in new cancers or tested in combination with other therapies. In recent years, Bailey has helped design and run trials aimed at preventing cancer among at-risk populations such as organ transplant recipients.
 
"It is very rewarding to see the program develop to a point where, today, we're finding and testing new drugs that might prevent cancers, as well as, treat them," he says.

Yet Bailey cannot consider the many accomplishments of Phase I trials without being awed by the invaluable contributions patients make to these investigational studies: "The patients and the families make this research very enjoyable; they’re wonderful to work with," he says.

"We know from others' research and our own observations that most people who enroll in a cancer study do so because they hope it helps them … yet I continue to be amazed, ultimately, at how resilient and honorable people are," Bailey says.

"They want help for themselves, but they are also willing to help others they may never know."
 
Pictured above are the Phase I Clinical Trial staff. Missing are Heidi Brandon and Molly Houston.
 

Date Published: 03/14/2008


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