LaBahn Pancreatic Cancer Program's Purple Post: Volume 2 Issue 2
PURPLE POST PURPLE POST
The beautiful Wisconsin summer is upon us! In this issue of the Purple Post, we are shining a spotlight on our team of investigators that help support clinical trials for pancreatic cancer Many may have heard of the term "clinicaltrial”orevenparticipatedinone.Clinicaltrialsarestudieswhichare performedinhumansandrepresentaculminationofpriorworktoidentifybetter waystotreatdiseases.Ingeneral,clinicaltrialsoftenrepresentthecuttingedgeof cancercare,andpatientswhoparticipateinclinicaltrialshaveaccessto treatmentsbeforetheyarewidelyavailable.Clinicaltrialsareconductedwith strictadherencetoprotocols,toensurethesafetyoftheparticipantsaswellasthe highqualityoftheinformationbeingcollected.Thisrequiresadedicatedteamof specialistswhooverseeawiderangeofactivities,fromregulatoryoversightto monitoringofadverseeventsandtoxicities.Inthisissue,Dr.BenGeorge,whois theDirectoroftheMedicalCollegeofWisconsinClinicalTrialsOffice,sharesthe accomplishmentsofthelastyearandidentifiesfutureareasofinterest.Haley Heaviland,oneoftheclinicalresearchcoordinators,givesabehindthesceneslook atwhatgoesintomonitoringaclinicaltrial.
Inaddition,wearepleasedtoannouncethatwehavebeenselectedtoparticipate inthePANCANPrecisionPromiseAdaptiveClinicaltrialwhichwillofferpatients with metastatic pancreatic cancer unique opportunities to receive novel therapeuticsAndfinally,summerissynonymouswiththegreatAmericanpastime ofbaseball.WewerefortunatetoparticipateintheannualSeenaMagowitz Foundation’s“DinnerontheDiamond”whichcelebratedpancreaticcancer survivorsandraisedfundsforpancreaticcancerresearchandclinicaltrials.This summer,Ihopethatyouarefindingtimetorelax,reconnectwithfriendsand family,andenjoythebeautifulweather.
Left to right: Ryan Ugalde, Kay Kays, Manny Garcia, Judy Green, Dr Michael Gordon, Ron Brefka, Dr Vivian Pearlman, Michael Francis, Stan Vitkas, Kathy Lee, Janet Bor, Johnny Ringo, Dan Winkelman, Roger Caplinger, Craig Hellmers, attendees at the recent Power of Us event in Phoenix, AZ
Susan Tsai, MD, MHS- Director, LaBahn Pancreatic Cancer Program
Purple Post Purple Post
The Purple Post Newsletter is a publication by the LaBahn Pancreatic Cancer Program to provide patients, family, and loved ones with informative and current topics at the Medical College of Wisconsin. Issue are published every February, June, and October.
Art + Production
Lori Keiser, BS, MA
Melissa Mena, BS, CCRC
Editing
Beth Krzywda, APNP
LaBahn Pancreatic Cancer Program Director
Susan Tsai, MD, MHS
LaBahn Pancreatic Cancer Program
8701 W Watertown Plank Rd Wauwatosa, WI 53226 mcwpancreas@mcw.edu
All rights reserved No part of this publication may be reproduced by any means, prints, electronic, or any other, without prior written permission of the publisher.
For questions, comments, or to submit an idea for an upcoming newsletter, please contact us at mcwpancreas@mcw.edu or 414955-1423
C L I N I C A L T R I A L S
By: Ben George, MD, Jennifer Bollmer, and Lori Keiser
Clinical trials are research studies that involve people They are often the final step in a long process of testing new therapies or therapeutic strategies Clinical trials are considered essential to improve the care of all patients with cancer, as many treatments used today are the result of past clinical trials In 2012, at the Clinical Trials Office (CTO) was established at MCW’s Clinical Cancer Center to provide a centralized infrastructure for the development, enhancement, and execution of cancer clinical trials.
There are currently over 130 full-time staff working in the CTO, with the plan to expand to over 150 staff members by 2023. Each disease team has dedicated staff to help with the regulatory and financial aspects of the trial, and the CTO has additional staff members to help with education and quality assurance. CTO staff are integral to ensure that clinical trials are conducted with a high level of scientific and ethical oversight. This helps to ensure that the trial is safe and has accurate and meaningful results.
In 2021, 103 patients at the Medical College of Wisconsin were enrolled into National Clinical Trials Network clinical trials. These are large clinical trials which are conducted across many centers across the country and often set the standard of care for oncology practice. In addition, in the last year, 132 patients (22%) were enrolled in precision medicine trials. These trials utilized targeted therapies which are tailored to vulnerabilities that may be present in the tumor. In addition, there were 143 earlyphase interventional treatment trial participants compared to 81 in 2017. Early-phase trials represent novel therapeutics which have had evidence of being effective in the laboratory or in animals and are just beginning to be tested in humans.
Over the past five years, the CTO has experienced tremendous growth as evidenced by the following statistics:
Treatment accrual increased 49%
Total interventional accrual increased 26%
Early phase treatment accrual increased 77%
The CTO has ambitious plans and will be focused on 6 major efforts. Specific areas of interest include: 1) increasing the total number of treatment trials and trial participants since its inception in 2012, 2) increasing the focus on precision oncology clinical programs, 3) addressing disparities in clinical trial research by planning clinical trial education centers in underserved areas of the Milwaukee community, 4) increasing the relationships with similar academic institutions acrossthe country 5) increasing the enrollment into trials designed and led by MCW investigators , and lastly 6) expanding early phase (first in human) and cellular immunotherapy programs at MCW
Members of the solid tumor early phase clinical trials team at MCW
CLINICAL RESEARCH COORDINATORS AT MCW B E H I N D T H E S C E N E S
By: Haley Heaviland, Clinical Research Coordinator III
In the Clinical Trials Office (CTO), many people work behind the scenes on clinical trials, but to patients, there is one person that serves as the face of the CTO- the clinical research coordinators (CRC) or clinical research nurses (CRN) A patient’s first interaction with us often begins with the study informed consent This discussion may be the only interaction with us, or depending on the protocol we may see patients frequently over the course of a trial During the trial we may meet with patients for questionnaires, assessments, exchanging diaries, returning medications or specimens, scheduling appointments or a check-in Considering that your CRC or CRN may play quite a big part of your clinic visit, it maybe surprising to learn that the time spent in clinic accounts for 10% or less of their work
As you can see, coordinators have many responsibilities but at the end of the day, they are here to help patients through clinical trials safely and effectively. They work tirelessly with a variety of people to support research and advance new therapies and technologies. The role is often behind the scenes, but vital in treating patients with pancreatic cancer
Pictured Above: Barb Dion, Haley Heaviland, Kati Hallada, Megan Memmell
Pictured Above: Gastrointestinal/Gentiourinary Cancer coordinators & assistants
CURRENT CURRENT Clinical Trials
TRIALS FOR LOCALIZED PANCREATIC CANCER
S O F T T R I A L
GOAL: To determine how to best give radiation therapy prior to surgery.
Study Design: Patients with resectable, borderline resectable, or locally advanced
pancreatic cancer are eligible. Patients are randomized to either a long course of preoperative chemotherapy and radiation given together over about 5.5 weeks or a shorter course of preoperative therapy with a higher dose of radiation given over about 1.5 weeks or 5 total treatments.
P A N C T R I A L
GOAL: To learn more about how to best adjust the chemotherapy which is given before surgery (neoadjuvant chemotherapy) to maximize its effectiveness.
Study Design: Patients with resectable and borderline resectable pancreatic cancer are eligible. This utilizes serial monitoring of a tumor marker (CA 19-9) in the blood and radiographic imaging, to guide changes to neoadjuvant chemotherapy to optimize the ability to receive all neoadjuvant therapy and surgery.
N C R E A S T R I A L
GOAL: To determine if specific molecular characteristics of the tumor predicts responsiveness to chemotherapy. P A
Study Design: Patients with resectable and borderline resectable pancreatic cancer are eligible Tumor samples will be taken for molecular profiling The molecular characteristics of the tumor will help determine the type of chemotherapy that is given for neoadjuvant therapy
TRIALS FOR METASTATIC PANCREATIC CANCER
E C O G - G I A N T
GOAL: To determine which of two chemotherapy treatment combinations, Gemcitabine and Nabpaclitaxel (GnP) or 5-Flurouracil, Leucovorin, and Liposomal Irinotecan (Naliri), is more effective at improving overall survival in patients over the age of 70 years with metastatic pancreatic cancer.
Study Design: Patients with metastatic pancreatic cancer who have not previously undergone therapy are eligible Patients are randomly assigned to receive GnP or Naliri
FAETH-THERAPUTICS
GOAL: To determine if dietary changes (via amino acid restriction) may be an effective strategy to treat multiple types of cancer
Study Design: Patient with metastatic pancreatic cancer who have not previously undergone therapy are eligible All subjects will receive NEAAR (nonessential amino acid restricted) medical food in addition to standard of care FDA-approved chemotherapy consisting of Gemcitabine and Nabpaclitaxel Each week, NEAAR medical food will be consumed 5 consecutive days followed by 2 days of usual diet
For more information and to see the most up-to-date list of clinical trials at MCW, scan the QR code with your smartphone or visit: https://www froedtert com/researc h/clinical-trials/cancer
Precision Promise
PANCREATIC CANCER ACTION NETWORK'S NEW ADAPTIVE CLINICAL TRIAL
Pancreatic Cancer Action Network, or PanCAN, has a new and exciting clinical trial opportunities for patients with metastatic pancreatic cancer. Its Precision Promise adaptive clinical trial is a pioneering effort to fast-track new treatment options to accelerate the access to new and promising therapeutics. PanCAN is bringing together leading experts and stakeholders – researchers, clinicians, industry, and pancreaticcancerthought-leaders–tomakethishistoricinitiativepossible.
Precision Promise was created because traditional clinical trial designs are often slow to evaluate new treatmentoptionsforpancreaticcancerpatients.ThedesignofthePrecisionPromiseadaptiveclinictrial willmoreefficientlytestnewtherapiesbyreducingthenumberofpatientsneededandrequiringlesstime than traditional clinical trials. This adaptive clinical trial tests multiple new drugs and combinations, comparing them to standard of care therapy in patients with metastatic pancreatic cancer. It is also designed to allow for multiple investigational therapies to be tested at the same time. Precision Promise willbeacentralhubfordatacollection,collaboration,andclinicaladvancementforresearchinpancreatic cancer
PanCANiscollaboratingwithaconsortiumofleadinginstitutionsacrosstheUnitedStatestodesignand manage pancreatic cancer research and clinical trials Through a competitive, peer-reviewed process, Froedtert & the Medical College of Wisconsin has been selected as one of the sites and will be opening enrollment in the Precision Promise adaptive clinical trial in near future. Patients with metastatic pancreaticcancerwhohaveneverpreviouslybeentreatedorhavehadonlyonepriortreatmentmaybe eligible.Staytunedfortheofficialannouncementofthetrialactivation.
PanCAN's Precision Promise allows researchers to do the following so treatments can be developed more quickly and efficiently
I’m a survivor.” Words that echoed throughout Chase
The Seena Magowitz Foundation hosted the Power of US Event in Phoenix as a celebration of survivors of pancreatic cancer This event gathered physicians, scientists, ambassadors, health care providers, survivors and supporters to collaborate on the latest research and pancreas cancer care. The Power of US reflects the synergy of this special event. Several MCW patients attended in person while a greater number of MCW patients were among those on a dedicated website highlighting long term survivors and their inspiring stories (see link on page 1).
Many attendees showed up dressed to fit the attire "Western" themesporting plaid, jeans, or cowboy boots We first gathered at the entrance of Chase field where we were greeted by tour guides
By: Melissa Mena
They walked us through the stadium, bringing us behind the scenes to show off a "Honus" Wagner's T206 Baseball card, sold in 2021 for over 6 6 million dollars We ended the tour in the dugout where guests posed for pictures and explored the bench from the player's perspective
As a spectator, its not often that you get to see so many survivors in one place You know the commonly reported statistics for pancreatic cancer survivors and feel lucky you get to meet any But in Arizona, I met 31 survivors, many of which were over five years out from their diagnosis Even more shocking was meeting those diagnosed with metastatic disease, deemed long-term survivors, like Elise Roth Tedeschi. She was diagnosed in 2012 at age 43 with stage four disease. She is now 10 years out with no evidence of disease. I was stunned when I ate dinner with another survivor, Manny Garcia, diagnosed at age 26. While most patients are diagnosed in their later years, it's not unheard of to come across someone young with the disease. Manny enrolled into a clinical trial where he received an experimental combination of chemotherapy. He is now three years out from his original stage four diagnosis.
Over dinner, the survivors took turns recanting their journeys to the audience. It was awe-inspiring and a privilege to hear. While they spoke of different experiences, a theme presented consistently in their stories- having hope, keeping positive and working together in the fight against pancreatic cancer.
Pictured Above: MCW patients and survivors Ron Brefka (left) & Roger Caplinger (right)
Pictured Above: Manny Garcia (left) & Dr. Michael Gordon (right)
Pictured Above: Dan Winkelman (left) & Teona Ducre (right)
SUPPORTIVE CARE FOR CANCER PATIENTS
At Froedtert & the Medical College of Wisconsin, we believe in treating the whole patient, not simply their disease. Our Cancer Network provides access to a full range of support services that address the physical, emotional, social, and spiritual needs of patients and their families. Below is a list of services available to patients. Scan the QR code below to learn more about these services.
24 Hour Clinic
Adolescent & Young Adult
cancer Program
Art Therapy
Cancer Support Groups and Classes
Cancer Rehabilitation
Child Life Services
Counseling and Emotional Support
Fertility Preservation
Home Care and Hospice
Jeffery C Siegel Quality of Life Center
Nutrition
Palliative Care
Small Stones Wellness Center
Social Services
www.froedtert.com/cancer/support
LABAHN PANCREATIC CANCER TEAM SPOTLIGHT
What is your role at MCW and how long have you been a part of the team?
I am Clinical Research Coordinator III and the Team Lead for the GI/GU team aka The Rolling Stones I joined the team in August 2014 as a Clinical Research Assistant II I have worked in some aspect of research for MCW since 2007 when I started at MCW in the Biomedical Resource Center
What do you enjoy most about the work that you do?
Being a small part of the effort to raise the bar for overall survival for cancer patients in general and pancreas cancer patients specifically. I have lost several loved ones to cancer but am also incredibly fortunate that my dad, my sister and myself are all long-term cancer survivors (and all had treatment or surgery at MCW) I also feel really privileged to be working with a truly inspiring group of dedicated and motivated health care professionals in the pancreas program and on my team in the CTO
What are some of you interests and hobbies outside of work?
Haley Heaviland, ALB, CCRP Clinical Research Coordinator III
My wife and I love to travel, especially places we can hike, snorkel, get out on the ocean, or see wildlife in their natural habitat Alaska and Mexico are our two favorite places to go In the last couple of years I’ve developed a houseplant collection both at home and at work and have somehow become plant lady in our office taking care of about 40 plants around our offices on breaks/lunches/after hours I have three very adorable but naughty cats which tends to make having plants in the office a little easier than having plants at home
