Southeast Cancer Control Consortium Spring Meeting

1. Southeast Cancer Control Consortium Spring Meeting The Proximity Hotel Greensboro, NC Friday, April 25, 2014 8:30 am James N. Atkins, MD Principal Investigator Judith O. Hopkins, MD Co-Principal Investigator A Community Clinical Oncology Program (CCOP) funded by the National Cancer Institute (NCI)

2. New SCCC Physicians • Asheville, NC Ashley Case, MD - Gyn Onc Blair Harkness, MD - Gyn Onc David Hetzel, MD - Gyn Onc Timothy Vanderkwaak, MD - GynOnc • Charlotte, NC IlanAvin, MD - Surgeon NusratChaundhary, MD – Med Onc Adam Kuykendal, MD – Med Onc Peter Turk, MD - Surgeon

3. Danville, VA • Ashantice Higgins, MD - Med Onc • Gastonia, NC • John Heinzerling II, MD - Rad Onc • Goldsboro, NC • Debra Miller, MD – Med Onc • High Point, NC • Bernard Chinnasami, MD - Med Onc • Grace Kim, MD - Rad Onc

4. Savannah, GA • James Burke, II, MD - Gyn Onc • James Garber, MD - Surgery • Patrick Hammen, MD - Surgery • Robert Jones, MD - Surgery • Guy Petruzelli, MD - Surgery • Scott Purinton, MD - Gyn Onc • Raymond Rudolph, MD - Surgery • Christopher Senkowski, MD - Surgery

5. New Community Leader Greensboro, NC: Community Leader James Granfortuna, MD

6. SCCC Accrual Credits Year 27 (6/1/13 – 2/28/14)

7. Year 26 Accrual by Research Base

8. Accrual Requirements Normally accrual projections for each component are based on the number of current SCCC members within a component Example: 2 x # MDs = projection

9. Revised Accrual Requirement Due to the lack of available protocols for common diseases (breast, colon, and lung), the component accrual requirement will not be enforced for the current grant year (6/1/13 to 5/31/14). We continue to encourage investigator participation in clinical trials for all cancer patients.

10. Treatment Credit Accrual

11. Cancer Control Credit Accrual

12. SCCC 6 Month Accrual 6/1/13-11/30/13 RX Accrual 108 = 78.7 Credits CC Accrual 163 = 120.4 Credits

13. SCCC 9 Month Accrual 6/1/13 – 2/28/14 RX Accrual 135 = 97.1 Credits CC Accrual 211 = 146.9 Credits

14. SCCC Accruals per Component 6/1/13 – 2/28/14

15. SCCC Accruals per Component 6/1/13 – 2/28/14

16. Pharmaceutical Management Branch (PMB)Oral Drug Accountability Record Form (DARF) New NCI Oral DARF available March 1, 2014 • SCCC has pre-populated NCI Oral DARFs and Regular IV DARFs • Available on SCCC member website – use following links to obtain: View Community Clinical Trials → Disease → Protocol → Related Documents → Drug Listing = DARF (ability to complete DARF online and save as document)

17. Pharmaceutical Management Branch Oral Drug Accountability Record Form (DARF)

18. NCI National Clinical Trials Network (NCTN)There will be a total of 7 NCTN groups: 4 Adult Groups (legacy cooperative groups - some merged) • Alliance (ACOSOG, CALGB, and NCCTG) • EGOG - ACRIN (ECOG and ACRIN) • NRG (NSABP, RTOG, and GOG) • SWOG (remained solo) 1 Pediatric Group • Children’s Oncology Group (COG) 2 Cancer Center Research Base Groups from the following: • CCCWFU, MD Anderson, SunCoast, and URCC

19. National Clinical Trials Network (NCTN) • Became effective March 1, 2014 • Transition process did not go as smoothly as NCI • expected • CTSU and all research bases experienced difficulties • Many hours spent in SCCC Operations Office thru phone • calls and emails to resolve issues – over 300 SCCC members to input info into system • All components and their affiliates/clinics/etc. have • performance site codes

20. NCTN Working Group • Meeting held at NCI in Rockville, MD on Wednesday, March 26 • Composed of 2 Co-Chairs and 28 extramural members – Jim Atkins, MD is a member • Conducted 4 face-to-face meetings to date • One more meeting may be conducted • Have reviewed all clinical trials within the NCI portfolio

21. NCTN Working Group • Responsibilities: • Assess strength and balance of active NCTN clinical trials portfolio • Recommend new strategic priorities and directions • Review and assess the Clinical Trials Working Group evaluation process and results • Provide strategic advice to enhance NCTN clinical trial operations

22. NCTN Working Group • Meeting highlights: • One of the Steering Committees now has new membership • All clinical trials accruing over 1000 patients are on hold

23. NCTN Working Group (Meeting Highlights cont.) • Total registrations for all 4 adult groups are 12,000 pts/year (3,000/group) – down from 25,000-30,000/year in the past (12,000 does not include accruals to Match or Alchemist) • Steering Committees will rank Phase II and III trials (select protocols on hold) plus assess funding and # patients going on clinical trials

24. Performance Site Codes • Also referred to as NCI CTEP institutional codes • Utilized for patient registrations • NCI wants the capability of identifying where patients are cared for/treated/consented • Site code designated at registration is the location where the majority of patient assessment (MD visits) for the research study is done. Treatment and/or consenting may be done at another location.

25. CCOPSYS • The database system utilized to store/access CCOP information. • Provides: • CCOP Description, Components (institutions), Persons (SCCC • members - MDs, CRPs, RNs, etc.), Role Assignment within • Operations Office, Research Base Rosters, History of SCCC, and • required membership documents • Quarterly Accrual Submission and Yearly Budget • Historical Accrual Reports and Demographics of Accruals • (male and female) • Meeting presentations from CCOP PI/Administrators meetings

26. NCI Central Institutional Review Board (NCI-CIRB) • Sole IRB of record responsible for study review as well as review of local context considerations via study-specific worksheets • Local Institutional Key Responsibilities: • Report unanticipated problems or serious/continuing • noncompliance • Merging local boilerplate text/language into • CIRB-approved consent form

27. NCI Central Institutional Review Board (NCI-CIRB) • SCCC Component NCI-CIRB Involvement/Progress • Six components are presently utilizing • Seven components have submitted applications – pending approval • Five components are in the process of completing the application • Approximate #s since approval process changes weekly/monthly

28. NCI-CIRB • Three current CIRBs and one more added in future: • Adult CIRB -Late Phase (16 members) – reviews all Phase III studies (since 2001) • Adult CIRB - Early Phase(10 members) – reviews early phase studies (since 2013) • Pediatric CIRB (16 members) – reviews all COG studies (since 2004) • Cancer Control/Prevention CIRB – member solicitation has begun to form CIRB during 2014

29. Components Involved in ACOSOG and GOG ACOSOG:GOG: Asheville Asheville Charlotte Charlotte Savannah Greensboro Kingsport Pinehurst Savannah Winston-Salem New Member: Hope Women’s Cancer Center - ACOSOG and GOG participating physicians located in Asheville, NC

30. ACCRU through Alliance • Participation now available through SCCC for ACCRU studies since drug is distributed directly to components by Biologics for many studies • One recurrent/metastatic breast cancer study available (RU011201I) with more to come • - One component approved to participate • - Several components are applying for participation

31. Alliance Executive Committee RetreatMarch 28-29, 2014Miami, FL • Group Chair: Monica M. Bertagnolli, MD • All 4 NCTN group chairs composed a letter to Harold Varmus, MD (NCI Director) that addressed poor protocol selection, decreased number of trials, and IOM recommendations. • ASCO article received via Alliance membership • Letter addressed budget cuts, end of CCOP funding, and lack of clinical trial research available

32. Summary • NCTN Research Bases must be unified and work together • Majority of clinical trials will be Phase II although the need for Phase III has been emphatically expressed • Credit the majority of your registrations through CTSU to Alliance

33. Summary cont. • Message conveyed: “clinical trial system is being dismantled in the US” • Consider increased participation in industry trials • NCTN Research Bases are planning to conduct large Phase III trials through foundation support if NCI does not support the trial

34. NCI Community Oncology Research Program (NCORP) • Timeline: • NCORP Application received at NCI on January 8, 2014 • Peer Review scheduled for Community Sites is April 24-25, 2014 with scoring posted within a few days – the lower the score the better (ideal 20-30) • Application scores along with summary statement including comments from reviewers will come later • NCI Advisory Review (2nd level) scheduled for June 2014 • ? determines funding • NCORP anticipated start date around August 1, 2014

35. New Documents • Drafted documents: • ByLaws • Consortium Agreement • Governing Council Responsibilities • Executive Board Responsibilities • Component Responsible Investigator Responsibilities • Study Coordinator Responsibilities

36. CCOP to NCORP Transition • CCOP funding ends May 31, 2014 – able to pay all CCOP expenses up to that point (payment may occur in June for some expenses) • SCCC will apply for “no-cost extension” of funds (leftover funds) remaining from CCOP award for 6/1/13-5/31/14 • All expenses from 6/1/14 until NCORP funding is awarded will come from leftover CCOP funds • All accruals from 6/1/14 will be extended CCOP credits

37. CCOP to NCORP Transition • SCCC Operations Office will continue to function as normal • Registrations will still occur to protocols and will be considered accruals to NCORP from June 1, 2014 forward • Official merge of SCCC with Upstate will occur when NCI awards NCORP funding – have legal matters to address with the merge

38. SCCC-Upstate NCORP Community Site Introductions on Planned Infrastructure PIs: James N. Atkins, MD James D. Bearden, III, MD, FACP (Spartanburg, SC) Co-PIs: Judith O. Hopkins, MD (Winston-Salem, NC) Patricia C. Griffin, MD (Spartanburg, SC)

39. SCCC-Upstate NCORP Community Site Young Investigators-in-Training: Franklin L. Chen, MD (Winston-Salem, NC) Amarinthia (Amy) E. Curtis, MD (Spartanburg, SC) Steven M. Duffy, MD (Richmond, VA) William (Billy) J. Irvin, Jr., MD(Midlothian, VA) Sharmila P. Mehta, MD (Spartanburg, SC) Sarah I. Vidito, MD (Spartanburg, SC)

40. SCCC-Upstate NCORP Community Site Infrastructure Governing Council Composed of PIs, Co-PIs, Young Investigators-in- Training, Administrators, and CCDR Coordinator Executive Board Composed of Governing Council, 23 “Community Responsible Investigators” (formerly known as “Community Leaders”), and select Administrative Office Staff

41. Representation at NCTN Research Base Meetings (Pending Funding) Alliance:Jim Atkins, MD(med onc) Judith O. Hopkins, MD(med onc) Rick Orr, MD (surgeon) - Upstate Sarah Vidito, MD (med onc) – Upstate

42. Representation at NCTN Research Base Meetings Pending Funding NRG: Jim Atkins, MD(med onc) William J. Irvin, Jr., MD(med onc) Kevin Roof, MD(rad onc) James Burke, II, MD(gyn onc) Volker Stieber, MD(rad onc)

43. Representation at NCTN Research Base Meetings Pending Funding SWOG: James D. Bearden, III, MD, FACP (med onc) - Upstate Charles Kuzma, MD(med onc) Amy Curtis, MD (med onc) – Upstate Gary Spencer, MD (hem) - Upstate

44. Representation at NCTN Cancer Center Research Base (CCRB) Meetings Pending Funding CCRB #1: James D. Bearden, III, MD, FACP (med onc) - Upstate Drew Monitto, MD (rad onc) - Upstate Steven Duffy, MD(med onc)

45. Representation at NCTN Cancer Center Research Base (CCRB) Meetings Pending Funding CCRB #2: Judith O. Hopkins, MD(med onc) Sharm Mehta, MD (med onc) - Upstate Frank Chen, MD(med onc)

46. Questions ? ? ?

47. SCCC Fall Meeting Marina Inn at Grand Dunes, Myrtle Beach, SC October 23 – 25, 2014 Please make every effort to attend this vital meeting as final terms of the NCORP award and the merger with Upstate Carolina will be presented in detail. There will be Governing Council and Executive Board meetings.