Advisory Committee Members Present:
John Niederhuber, M.D., Deputy Director, NCI (Acting Chair)

Advisory Committee Members Participating in the Teleconference:
LaSalle D. Leffall, Jr., M.D., Charles R. Drew Professor and Chairman, Department of Surgery, Howard University College of Medicine
Margaret Tempero, M.D., Deputy Director, University of California, San Franciso, Comprehensive Cancer Center
Thea Tlsty, Ph.D., Professor, Department of Pathology, University of California, San Francisco
Douglas E. Ulman, Director of Survivorship, Lance Armstrong Foundation
Daniel D. Von Hoff, M.D., Senior Investigator/Director, Translational Research Institute (TGen) and Clinical Professor of Medicine, Arizona Health Sciences Center, University of Arizona Department of Medicine
Robert C. Young, M.D., President, Fox Chase Cancer Center

Ex Officio Members Participating in the Teleconference:
Paulette Gray, Ph.D., Director, Division of Extramural Activities, NCI
Alan Rabson, M.D., Deputy Director, NCI

Executive Secretary Participating in the Teleconference:
Cherie Nichols, M.B.A., Director, Office of Science Planning and Assessment (OSPA), NCI

Ad Hoc Sarcoma Panel Members Participating in the Teleconference:
Kevin C. Cullen, M.D., Director, University of Maryland Greenebaum Cancer Center
Peter W. T. Pisters, M.D., F.A.C.S., Professor of Surgery and Chief, Sarcoma Service, Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center
Scott Saxman, M.D., F.A.C.P., Senior Investigator, Cancer Therapy Evaluation Program, NCI (Content Expert Advisor to the Panel)
Margaret Tucker, M.D., Chief, Genetic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, NCI

NCI Staff
Jamelle Banks, Health Science Analyst, OSPA, NCI
James H. Doroshow, M.D., Director, Division of Cancer Treatment and Diagnosis, NCI
Maureen Johnson, Ph.D., Chief, Institute Review Office, NCI
Kathleen Schlom, Special Assistant to the Director, NCI
Lisa Stevens, Ph.D., Scientific Projects Manager, OSPA, NCI
Gretchen Weaver, Office of the General Council, NCI
Maureen O. Wilson, Ph.D., Assistant Director/Ethics Officer, NCI

Other Participants:
Ed Rorie, NOVA Research Company (Science Writer)

Purpose of the Teleconference

The purpose of the teleconference was to: (1) determine whether the key recommendation of the January 2004 Report of the Sarcoma Progress Review Group: A Roadmap for Sarcoma Research—formation of a Sarcoma Research Consortium—is consistent with the report’s scientific conclusions; and (2) consider a proposal to form an ACD working group, and eventually an official subcommittee, to guide implementation of the Clinical Trials Working Group (CTWG).

Ms. Cherie Nichols reminded participants of the purpose of the teleconference and confirmed that no conflict of interest existed that would prevent any ACD members from discussing the recommendations of the Sarcoma PRG or the CTWG. She noted that a summary of the teleconference will be posted on the public NCI Web site.

Dr. Young asked whether a vote by the ACD confirming the consistency of the recommendation with the report’s conclusions would mean that the ACD had approved the recommendation as the only one that could be derived naturally from the findings. Ms. Nichols replied that the Sarcoma Progress Review Group (PRG) report has already been accepted by the ACD; however, in an effort to ensure the absence of conflict of interest regarding the key recommendation in the report, an Ad Hoc Sarcoma Panel met to consider that recommendation’s scientific consistency with the report’s conclusions. A vote confirming consistency would not commit the NCI in responding to the report’s findings.

Presentations concerning the first topic were made by members of an Ad Hoc Sarcoma Panel; the second topic, concerning establishing an ACD working group to advise the CTWG, was presented by Dr. James Doroshow.

Presentations by the Ad Hoc Sarcoma Panel

Dr. Cullen stated that the recommendation is narrowly consistent with the report’s scientific conclusions. However, he added, the recommendation does not serve the best interests of sarcoma patients. There is no evidence that limiting sarcoma research to a few centers will be advantageous. Existing Cooperative Groups are already performing many of the proposed functions. The implications of the adoption of this model for future approaches to other rare diseases should be carefully considered.

Dr. Pisters stated that while the recommendation is consistent with the report’s findings, the proposed aims could be achieved through existing Cooperative Groups with some structural modification and additional funding; he noted that the PRG report did not address this option. He added that it would interesting to know whether NCI has any experience with similar disease-specific research consortia.

Dr. Tucker expressed support for the concept of a research consortium but was concerned about details in the report concerning its proposed structure, governance, and funding. She agreed that the issues raised in the report could be addressed through modifications of existing Cooperative Groups and pointed out that a freestanding organization might be difficult to manage.

In written comments submitted prior to the meeting, Drs. Judy Garber and Felicia Hodge found the recommendation to be consistent with the report’s findings.

Discussion

Dr. Young stated that he agreed with the Panel that the key recommendation of the Sarcoma PRG is consistent with the report’s scientific conclusions. He also shared the reservations expressed by several Panel members that a consortium may not be the best solution to problems identified in the report. Creation of a separate group may be problematic in terms of peer review; it could establish this model as a precedent for addressing rare tumors. Several alternatives that are available to supplement existing efforts would provide better opportunities to monitor the process.

Dr. Leffall stated that he shared Dr. Young’s concerns.

Dr. Tlsty agreed, emphasizing that the proposed consortium is not the best approach.

Mr. Ulman agreed with Drs. Young, Leffall, and Tlsty and expressed strong doubts concerning the need to create a new bureaucracy to direct sarcoma research.

Dr. Doroshow noted that the Clinical Trials Working Group (CTWG) plans to create a Sarcoma Steering Committee that will bring together researchers conducting sarcoma-related clinical research, including those working in Cancer Centers and SPOREs in addition to those working in Cooperative Groups.

Dr. Leffall moved that the ACD accept the Ad Hoc Sarcoma Panel’s conclusion that the key recommendation of the Sarcoma PRG is consistent with the report’s scientific conclusions. The motion was seconded by Mr. Ulman.

In discussion, Dr. Tlsty asked that the motion be amended to state that the recommendation is “narrowly” consistent with the PRG report’s conclusions. The ACD unanimously accepted this amendment.

Dr. Tempero abstained from voting because, due to technical difficulties, she had joined the discussion late and did not hear all of the presentations. All other ACD members voted to approve the motion.

Members of the Ad Hoc Sarcoma Panel exited the teleconference at this point.

Discussion of the Proposed ACD Working Group to Guide the CTWG

Dr. Doroshow explained that NCI would like to establish an advisory group to guide implementation of the CTWG through a change in the ACD charter. The proposed change would allow the formation of ACD subcommittees as well as the inclusion of members of other NCI advisory groups and ad hoc members of the extramural community with appropriate expertise.

Because changing the ACD charter will take months, formation of a working group has been proposed to provide guidance while the charter is being revised. Dr. Gray noted that there are no restrictions on forming working groups while the formation of subcommittees is pending.

Dr. Young moved that the ACD approve the formation of a working group for this purpose, and Dr. Leffall seconded the motion. The motion was approved unanimously.

Dr. Doroshow stated that he would contact ACD members to determine their interest and availability regarding the working group.

Adjournment

The teleconference adjourned at 11:45 p.m.