Southeast Cancer Control Consortium Spring Meeting

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Southeast Cancer Control Consortium Spring Meeting

The Proximity HotelGreensboro, NC

Friday, April 25, 20148:30 am

James N. Atkins, MDPrincipal Investigator

Judith O. Hopkins, MD Co-Principal Investigator

A Community Clinical Oncology Program (CCOP) funded by the National Cancer Institute (NCI)

New SCCC Physicians • Asheville, NCAshley Case, MD - Gyn Onc Blair Harkness, MD - Gyn Onc David Hetzel, MD - Gyn Onc Timothy Vanderkwaak, MD - Gyn Onc

• Charlotte, NCIlan Avin, MD - SurgeonNusrat Chaundhary, MD – Med OncAdam Kuykendal, MD – Med OncPeter Turk, MD - Surgeon

• Danville, VA Ashantice Higgins, MD - Med Onc

• Gastonia, NCJohn Heinzerling II, MD - Rad Onc

• Goldsboro, NCDebra Miller, MD – Med Onc

• High Point, NCBernard Chinnasami, MD - Med OncGrace Kim, MD - Rad Onc

• 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

New Community Leader

Greensboro, NC: Community Leader James Granfortuna, MD

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

  Community AccrualsProjected/Actual

ActualCredits

NCI AssignedQuota Credits

CreditsNeeded

RX 183/135 97.1 200 102.9

CC 183/148 131.5 200

CC F/U 63 15.4 n/a

CC Total 146.9 53.1

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Year 26 Accrual by Research Base 6/1/13 – 2/28/14

Research Base

RX CC Totals

Alliance (CALGB) 31 21 52CCCWFU N/A 13 13

CTSU 49 9 58NSABP 38 40 78RTOG 7 11 18SCUSF N/A 9 9 SWOG 10 88 98 URCC N/A 20 20

Totals 135 211 346* * does not include: 0 credit accruals or follow-up FRP accruals: 129

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

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.

Baseli

ne

1st Q

uarter

2nd Q

uarter

3rd Q

uarter

4th Q

uarter

0

100

200

300

41.1

78.797.1

0

50

100

150

200

SCCC TREATMENT CREDIT ACCRUALACTUAL vs NCI QUOTA

06/01/13 - 02/28/14

ACTUALNCI QUOTA

TREA

TMEN

T C

RED

ITS

Treatment Credit Accrual

Baseli

ne

1st Q

uarte

r

2nd Q

uarte

r

3rd Q

uarte

r

4th Q

uarte

r0

100

200

300

66.2

120.4146.9

0

50

100

150

200

SCCC CANCER CONTROL CREDIT ACCRUALACTUAL vs NCI QUOTA

06/01/13 - 02/28/14

ACTUAL

NCI QUOTA

CAN

CER

CO

NTR

OL

CR

ED

ITS

Cancer Control Credit Accrual

SCCC 6 Month Accrual6/1/13-11/30/13

RX Accrual 108 = 78.7 CreditsCC Accrual 163 = 120.4 Credits

SCCC 9 Month Accrual6/1/13 – 2/28/14

RX Accrual 135 = 97.1 CreditsCC Accrual 211 = 146.9 Credits

SCCC Accruals per Component6/1/13 – 2/28/14

Community RX CC Industry Total ComponentAccrual Req

Asheville, NC 13 4 27 44 36

Cary, NC 5 7 0 12 4

Charleston, SC 9 4 2 15 30

Charlotte, NC 16 26 22 64 38

Danville, VA 1 0 0 1 4

Florence, SC 2 3 0 5 10

Gastonia, NC 5 5 0 10 16

Goldsboro, NC 14 10 0 24 16

Greensboro, NC 24 21 28 73 44

Hendersonville, NC 1 6 0 7 12

SCCC Accruals per Component6/1/13 – 2/28/14

Community RX CC Industry Total ComponentAccrual Req

High Point, NC 2 2 10 14 12

Kingsport, TN 16 1 30 47 30

Martinsville, VA 1 1 0 2 4

Pinehurst, NC 9 19 10 38 14

Richmond, VA 0* 0 0 0 8

Savannah, GA 4 4 0 8 20

Statesville, NC 3 0 0 3 8

Winston-Salem, NC 10 43 0 53 46

Total 135 156 129 420 352

* New Component - 1st registration March 2014 QOL registrations not included

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)

Pharmaceutical Management Branch Oral Drug Accountability Record Form (DARF)

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

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

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

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

NCTN Working Group

Meeting highlights:• One of the Steering Committees now

has new membership• All clinical trials accruing over 1000

patients are on hold

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

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.

CCOPSYSThe 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

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

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 applicationApproximate #s since approval process changes

weekly/monthly

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

Components Involved in ACOSOG and GOG

ACOSOG: GOG:Asheville AshevilleCharlotte CharlotteSavannah Greensboro

KingsportPinehurstSavannahWinston-Salem

New Member: Hope Women’s Cancer Center - ACOSOG and GOGparticipating physicians located in Asheville, NC

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

Alliance Executive Committee RetreatMarch 28-29, 2014

Miami, 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

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

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

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

New Documents

Drafted documents:• ByLaws• Consortium Agreement• Governing Council Responsibilities• Executive Board Responsibilities• Component Responsible Investigator

Responsibilities• Study Coordinator Responsibilities

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

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

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)

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)

SCCC-Upstate NCORP Community Site

InfrastructureGoverning 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

Representation at NCTN Research Base Meetings (Pending Funding)

Alliance: Jim Atkins, MD (med onc)Judith O. Hopkins, MD (med onc)Rick Orr, MD (surgeon) - UpstateSarah Vidito, MD (med onc) –

Upstate

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)

Representation at NCTN Research Base Meetings Pending Funding

SWOG: James D. Bearden, III, MD, FACP(med onc) - UpstateCharles Kuzma, MD (med onc)Amy Curtis, MD (med onc) –UpstateGary Spencer, MD (hem) - Upstate

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)

Representation at NCTN Cancer Center Research Base (CCRB) Meetings Pending Funding

CCRB #2: Judith O. Hopkins, MD (med onc) Sharm Mehta, MD (med onc) -

UpstateFrank Chen, MD (med onc)

Questions ? ? ?

SCCC Fall MeetingMarina 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.