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Medical Oncology Redefined:

A Conversation with the New Chief of the Medical Oncology Branch at CCR

Giaccone: Absolutely. This collaborative openness must extend to industry as much as to academia. Most drug development in oncology is conducted by industry these days. The MOB is working closely with the pharmaceutical industry to design and conduct studies that would not be feasible elsewhere or that require particular kinds of expertise. And we need to go further, to work with our industrial partners to identify important questions that must be answered but which cannot be studied in the context of industry sponsored studies.

We are in a very good place to run very early Phase 0 clinical studies—extremely small trials where you give a new drug to a limited number of patients under an exploratory investigational new drug (IND) protocol and develop reliable, reproducible assays that help determine whether the drug's behavior in people mirrors that in preclinical models. Comprehensive molecular studies on biopsies or molecular imaging studies on patients are very hard to conduct and are resource-intensive. But if they can be conducted in near real-time in an exploratory context, the data that they generate can help quickly and accurately determine next steps and properly define patient populations before moving into larger, later phase trials.

Connections: Is there a role for the so-called “big four” tumors (lung, breast, prostate, and GI) in the new MOB?

Giaccone: While rare tumors form a core focus of CCR, the four major tumor families will be well represented in our efforts, for two reasons. First, from a population standpoint, these tumors are the most important, affecting larger numbers of patients and causing the greatest mortality and morbidity. Second, a critical part of our mission is to train the next generation of medical oncologists and physician-scientists. We have one of the largest fellowship programs in the nation here at CCR. For the fellows to have the best training and gain the most from their experience, they need to be able to understand the common tumors before they can be expected to understand the uncommon ones.

We also have to consider how the major and rare tumors relate to each other and to CCR's mission. The major tumors each have many rare subtypes. Generally speaking, rare tumor types are biologically less complex than the major tumors. They tend to have fewer genetic alterations, making them easier to study biologically and facilitating their use as models for understanding the biology underlying the major tumors. The work of [Urologic Oncology Branch Chief] W. Marston Linehan, M.D., on kidney cancer and the VHL gene is a prime example of how one can leverage discoveries from a rare condition—namely, von Hippel-Lindau syndrome—to advance the understanding and care of more common conditions.

Connections: Can you give any other examples of the kinds of collaborative research you have been discussing?

Giaccone: CCR is now working with a researcher from Washington University in St. Louis, Samuel Wells, Jr., M.D., to conduct a trial here at the NIH Clinical Center focused on a rare hereditary form of thyroid cancer called hereditary medullary thyroid carcinoma (MTC).2 MTC accounts for 2 to 3 percent of all thyroid cancers, and only 25 to 40 percent of MTCs are hereditary. Thus, it is very difficult to collect a cohort large enough to do a study with meaningful power. Dr. Wells has teamed up with Frank Balis, M.D. [NCI Clinical Director and Head of the Pharmacology and Experimental Therapeutics Section in CCR's Pediatric Oncology Branch], to study a new targeted treatment option for patients with unresectable hereditary MTC, a study that likely would be impossible without CCR's research, resources, and reach.

Connections: What are the key elements for achieving this new strategic vision for the MOB?

Giaccone: Of all of the possible elements on the list, the most important is collaboration. You need a team approach and expertise from very different angles, from biology to patient care to symptom management, all combining to reach the best result. People in the different branches and sections recognize that we need to work together, not in isolation. But to bring us all back together, there needs to be a feeling that we all—all of the branches, all of the sections—are part of a larger enterprise.

Connections: What steps have been taken to make this vision of the MOB a reality?

Giaccone: Thus far, our efforts have primarily centered on bringing more integration and strategic planning into the clinical protocol development process. After consulting with the different MOB sections, my colleagues and I have developed a new planning step, called a concept review, designed to bring strategic consensus to protocol design. Before a protocol is written, we decide whether the question to be investigated is one that should be explored, and then we identify the resources needed, including those from other sections or branches. From there, we write the protocol collaboratively, ensuring that all details are addressed from the outset.

We also are actively involved in CCR's effort to reduce the time needed for protocol approval, with the goal of reducing that time to two months. This would make us extremely competitive with outside centers in terms of the speed with which we can translate discoveries into the clinic and also make us an attractive partner for collaborative efforts in clinical and translational research.

We are also actively reconstituting our lung, breast, prostate, and GI cancer programs. [MOB Investigator] William Dahut, M.D., has done well with the prostate cancer program for many years and will continue in his efforts to maintain its high standards. As head of the lung cancer program, I will be organizing the efforts of CCR's excellent team of lung cancer investigators. Leadership recruitment for the breast and GI programs, as well as our head and neck cancer program, is ongoing.

The MOB is a cancer research resource that exists to complement the excellent and mission-critical research that is being conducted nationwide.

Lastly, CCR has initiated a Medical Oncology Center of Excellence (CoE). The CoE, which I am leading, is bringing collaborators inside and outside of NCI— people doing important work in areas related to translational medical oncology research like molecular diagnostics, molecular target development, early detection, tumor imaging, and early therapeutics development—together in a multidisciplinary way.

Connections: If there is any one message you would want to convey to our readership about CCR, the MOB, and how its reconstitution will affect translational cancer research nationally, what would it be?

Giaccone: The MOB is a cancer research resource that exists to complement the excellent and missioncritical research that is being conducted nationwide. The MOB is not here to compete with centers that participate in NCI's extramural program, but rather we exist to enrich their work by offering capabilities and expertise that are not available at the extramural centers, and we can leverage these capabilities in unique ways. As our transformation continues, we look forward to building closer ties to our colleagues in academia and industry, so that together we can make the best use of what the MOB and CCR as a whole have to offer.