March 21, 2003

VICC one of 16 U.S. centers conducting Phase I trials

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Dr. Mace Rothenberg

VICC one of 16 U.S. centers conducting Phase I trials

The Vanderbilt-Ingram Cancer Center has been named among only 16 institutions that the National Cancer Institute looks to for expertise in conducting Phase I clinical trials of the newest and most promising cancer drugs.

The cooperative agreement with the NCI provides a modest amount of funding to support infrastructure — $115,000 per year over a five-year grant cycle. However, the importance of the designation as a Phase I center far exceeds the dollar amount, said Dr. Mace Rothenberg, professor of Medicine, Ingram Professor of Cancer Research and director of VICC’s Phase I Drug Development Program.

“By being recognized in this program, we are one of the 16 sites that the NCI looks to for the most innovative clinical, laboratory and translational research,” Rothenberg said. “It gives us an important seat at the table.”

Phase I clinical trials, as the very first test of new drugs in patients, represent an important linchpin between research that shows promise in the laboratory and ultimate advances in clinical care.

Phase I centers are expected under the cooperative agreement to conduct studies of new cancer therapies provided by the National Cancer Institute and the pharmaceutical industry.

“The number of new agents has grown exponentially over the past decade, from about 40 to about 350 at any given time,” Rothenberg said. “The NCI and the pharmaceutical industry really needs these centers to evaluate these new agents.”

Under its agreement, VICC will be expected to conduct at least one clinical trial each year.

“This will give us time to really ramp up slowly and do things right,” Rothenberg said. “In the first year or two of the agreement, I expect that one or two of the eight or 10 Phase I trials we conduct each year will be done through this agreement.”

Trials done under the agreement require rigorous reporting of data to the NCI on a bi-weekly basis. These trials include a strong translational component, including studies looking for biologic markers of drug activity.

The VICC will most likely use the infrastructure support from the NCI to cover personnel costs for tissue sample collection and informatics to maintain and process data, Rothenberg said.

The drugs that will be tested through the agreement are selected through a “Letter of Intent” process. The NCI periodically issues calls for these proposals, which are then peer-reviewed and those that are selected are then often tweaked further by the NCI. Any center can compete for these awards, but the designated Phase I centers have an advantage because they have NCI support for infrastructure, including coverage of personnel costs for tissue sample collection and informatics.

“A lot of the drugs we’ve chosen to evaluate, including COX-2 inhibitors and inhibitors of the epidermal growth factor receptor, illustrate how we can tie into our historical strengths in basic research,” Rothenberg said. “I anticipate that we’ll be able to put together some innovative and exciting proposals to spotlight these institutional strengths.”

The new designation adds to the VICC’s growing reputation in the cancer research community. Since the center was established 10 years ago, the center has grown in size, scope and stature. It earned the prestigious designation from the NCI as a Comprehensive Cancer Center and increased NCI funding to its investigators from just under $8 million per year to more than $42 million per year.