December 2015 Newsletter 
Clinical Trial Working Groups
  • Approved LOI:
    • ER+ and/or PR+ and HER2- breast cancer (Illinois)
    • AR+ triple negative breast cancer (Wisconsin)
  • Current concepts:
    • First line triple negative metastatic breast cancer (Penn State)
    • Newly diagnosed ER+, HER2- breast cancer (Minnesota)
    • Triple negative breast cancer (Wisconsin)
  • Next call: Wednesday, February 3 at 4 p.m. ET / 3 p.m. CT
  • Trial in start-up: Hepatocellular (Indiana)
  • Approved LOI:
    • Esophageal (Indiana) - see also thoracic
    • Gastric/GE junction adenocarcinoma (Northwestern)
  • Current concepts: 
    • Hepatocellular (Wisconsin)
    • Colorectal (Wisconsin) - on hold until Q1 2016
    • Pancreatic (Penn State)
  • Next call: Friday, December 18 at 3 p.m. ET / 2 p.m. CT; see you at GI ASCO!
  • Open trial: Renal cell carcinoma (Illinois)
  • Current concepts:
    • Bladder (Penn State)
    • Urothelial (Indiana)
    • Prostate (Rutgers)
  • In-person meeting: Thursday, January 7, 7:30 PT at Marriott Marquis in San Francisco
    (see details).
  • Trial in start-up: Endometrial carcinoma (Northwestern)
  • Current concept: Ovarian (Rutgers)
  • Next call: Friday, January 8 at 2 p.m. ET / 1 p.m. CT.
  • Current concepts:
    • Peripheral T-cell lymphoma (Michigan) -
      4 concepts, not yet presented
    • Cutaneous T-cell lymphoma (Michigan) -
      2 concepts, not yet presented
    • Lymphoma (Minnesota)
  • Next call: Wednesday, January 27 at 11 a.m. ET / 10 a.m. CT.
  • Current concepts:
    • Squamous cell carcinoma of the skin (Rutgers)
    • Melanoma brain metastasis (Michigan)
    • Uveal melanoma (Michigan)
  • Next call: TBD.
  • Current concept: Multiple myeloma and lymphoma (Indiana)
  • Next call: TBD.
  • Current concepts:
    • AML (Illinois)
    • AML (Indiana)
    • MDS (Penn State)
  • Next call: Tuesday, February 2 at 1 p.m. ET / 12 p.m. CT
  • Next call: TBD.
  • Approved LOI:
    • Esophageal (Indiana) - see also gastrointestinal
    • NSCLC (Illinois)
  • Current concepts:
    • Splice variants in lung cancer in women (Illinois)
    • HER2 expression and targeted therapy (Illinois)
  • Next call: Thursday, January 14 at 1 p.m. ET / 12 p.m. CT
 
To Discuss Protocols: Contact Jessica Roy at [email protected] or 317-634-5842, ext. 19

To Join a CTWG or Submit an LOI: Contact Donna LaPlaca Sullivan at  [email protected] or 317-634-5842, ext. 40.

Support the BTCRC
2015 Highlights in Review
Thank you for contributing to the Big Ten Cancer Research Consortium's success over the past year. Together we have achieved new milestones, increased participation within clinical trial working groups, and expanded both the number and diversity of concepts in the consortium's pipeline. During this holiday season, I am grateful for what we have accomplished. Following are just a few highlights:
  • The BTCRC launched its first clinical trial in March and accrued the first subjects in April. The study, evaluating the anti-PD-1 antibody pembrolizumab in combination with bevacizumab in the treatment of renal cell carcinoma, is open to accrual at six member institutions, with more sites opening soon.
  • 26 concepts from member institutions are currently in the development pipeline. Of these, 4 trials are expected to open to accrual in early 2016.
  • The neuro-oncology clinical trial work group formed in October, bringing the total number of working groups to 10.
  • In the past 2 years, more than 200 investigators have joined BTCRC clinical trial working groups. These groups provide a unique venue for the review of concepts while facilitating a culture of collaboration and mentorship.
  • Our website (www.bigtencrc.org) is now able to accept donations for the Big Ten Cancer Research Consortium Foundation. Additionally, contributions can be made to our member institution cancer centers through our website.
  • In August, the Big Ten Network began airing a promotional spot highlighting the consortium. This exposure has significantly broadened public awareness of the consortium.
As we move into a new year of opportunity, I want to thank you again for your partnership and commitment to our unified goal of improving the lives of all patients with cancer.


Susan Goodin, PharmD, Executive Officer
GU & GI ASCO Meetings

The BTCRC will host in-person meetings for the genitourinary, and gastrointestinal clinical trial working groups at national meetings noted below. Click the links for further details and to RSVP .
Featured Member Profile
Holden Comprehensive Cancer Center at the University of Iowa

" Rapid changes in cancer research are taking place in multiple dimensions at the same time. We are learning more every day about the incredible complexity of cancer genetics, cell biology, and how cancer interacts with normal tissues in the body including with the immune system. The big challenge is to continue to accelerate progress in our ability to understand cancer, and to use the information we have found to help as many patients as possible. This is requiring a new team approach to cancer research that includes basic cancer biologists, experts in informatics, clinical investigators, clinicians, and many others."

Read more in this conversation with George Weiner, MD, director of the Holden Comprehensive Cancer Center at the University of Iowa, our featured member for December. 

To see past member features, click here.
Q&A: Regulatory and Safety 
The December edition of our BTCRC FAQ series focuses on regulatory and safety. Questions addressed in this FAQ include:
  • What are the responsibilities of BTCRC regulatory managers?
  • What information should I send to the regulatory manager?
  • What are common errors?
  • If a trial requires an IND, who is the holder of the IND?
  • To what regulatory authorities should I report my SAE and who does the reporting?
  • When should I report the SAE?
 Read more. 
Across the Consortium
Big Ten Cancer Research Consortium members understand it takes the whole team to win the battle against cancer. By leading efforts to enhance diversity, members and consortium leadership are working hard to tackle disparities in clinical trial participation. Susan Goodin, executive officer of the BTCRC, was a panelist at a recent forum on clinical trial diversity in Chicago.

Also in this month's edition of Across the Consortium, we highlight the many ways our members are pushing the boundaries of science and technology in order to improve diagnosis, treatment, and other cancer-related experiences.    Read more .