October 9, 2020:

A Big Ten Cancer Research Consortium phase II study for adult patients with advanced salivary gland carcinoma that is androgen receptor positive (AR+), will test the combined therapy of the PD-1 inhibitor pembrolizumab and the androgen deprivation therapy goserelin. This multi-site study is now open to accrual at the University of Illinois Cancer Center (University of Illinois at Chicago); Holden Comprehensive Cancer Center, University of Iowa; University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center; University of Michigan Rogel Cancer Center; Masonic Cancer Center, University of Minnesota; Robert H. Lurie Comprehensive Cancer Center of Northwestern University; and University of Wisconsin Carbone Cancer Center.

The study, BTCRC-HN17-111, “Phase II trial of androgen deprivation therapy (ADT) and pembrolizumab for advanced stage androgen receptor-positive salivary gland carcinoma,” is being conducted to see whether blocking receptors in AR+ salivary gland tumors will cause the cells to stop growing or cause cell death.

Salivary gland tumors are rare, with an incidence of approximately 2.5 to 3 cases per 100,000 annually in the Western world, and account for 3 to 5 percent of all head and neck cancers. Currently, there is no standard therapy for treating this type of cancer. Patients with advanced AR+ salivary gland tumors are usually treated with either surgery, radiation, or chemotherapy.

“The objective of this study is to test the hypothesis that hormonal therapy with androgen deprivation therapy will increase the response rate to immunotherapy with pembrolizumab,” said Manish Patel, DO, sponsor-investigator of the study and a medical oncologist at the University of Minnesota Department of Medicine, Division of Hematology, Oncology and Transplantation. “What we will be looking at is the objective response rate or disease control with this combination in patients with androgen receptor positive salivary gland tumors.” Read More

October 9, 2020:

Big Ten Cancer Research Consortium investigators recently presented an E-Poster on the BTCRC-GU16-043 study during the ESMO 2020 Virtual Congress.

The clinical trial is investigating whether adding guadecitabine, a drug that targets DNA methylation, might increase the proportion of patients with advanced clear cell renal cell carcinoma (ccRCC) who respond to treatment with durvalumab, a checkpoint-inhibitor drug that targets the PD-1/PD-L1 pathway.

“In the past decade, checkpoint inhibitors have been a valuable addition to the therapeutic armamentarium of kidney cancer. However, not all patients benefit from this therapy, and there is an unmet need to further improve the clinical outcomes with novel combination strategies,” said co-author Rohan Garje, MD, a genitourinary medical oncologist and researcher at the University of Iowa Carver College of Medicine and Holden Comprehensive Cancer Center. “Preclinical studies have shown the synergy of hypomethylating agents and checkpoint inhibitors in enhancing anti-tumor efficacy. To evaluate this hypothesis, the ambitious collaboration of Big Ten Cancer Research Consortium members led to the development of this study. The preliminary safety results were presented at ESMO Virtual Congress 2020.”

See abstract.

Of the initial six patients enrolled in the study, the combination therapy was deemed safe with acceptable toxicity and promising anti-tumor efficacy. Guadecitabine at the dose of 45 mg/m2 SC daily for 5 days along with the standard dose of durvalumab (1500 mg, IV every 4 weeks on Day 8) was deemed safe for further evaluation.

The study authors include:

• Yousef Zakharia, MD – University of Iowa
• Yilun Sun, PhD – University of Michigan
• Rohan Garje, MBBS – University of Iowa
• Eric A. Singer, MD, MA, MS, FACS – Rutgers University
• Monika D. Joshi, MD, MRCP – Penn State University
• David J. Peace, MD – University of Illinois at Chicago
• Ajjai S. Alva, MBBS – University of Michigan

The phase II portion of the study is ongoing and additional results, along with biomarker correlatives, will be presented at future scientific meetings.

For more information on this clinical trial, including full eligibility requirements, visit clinicaltrials.gov (study #NCT03308396).

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to more than 9,800 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org.

October 1, 2020:

Applications are now open for a nationwide integrative oncology training program. The Integrative Oncology Scholars Program at the University of Michigan is funded by a National Cancer Institute R25 grant. It has the joint goals of training 100 integrative oncology (IO) leaders over 4 years and facilitating partnerships between IO leaders and complementary practitioners within their communities. Read More

September 29, 2020:

A phase Ib Big Ten Cancer Research Consortium multi-center study is testing the safety and efficacy of the monoclonal antibody gemtuzumab ozogamicin when combined with the BCL-2 inhibitor venetoclax in adults with relapsed or refractory acute myeloid leukemia.

The study is open to accrual at the University of Illinois Cancer Center in Chicago, Ill.; the Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis, Ind.; the University of Michigan Rogel Cancer Center in Ann Arbor, Mich.; and the Fred & Pamela Buffett Cancer Center at the University of Nebraska.

Acute Myeloid Leukemia, also known as AML, is a disease that occurs when the bone marrow creates abnormal myeloblasts (a type of white blood cell), or, less frequently abnormal red blood cells or platelets. In the United States, approximately 21,450 new cases occurred in 2019. Typically, adults age 65 and older are at greater risk of being diagnosed with AML and prognosis for survival remains poor, especially with relapsed or refractory disease.

People with AML are usually treated with chemotherapy and sometimes with targeted therapies.

The primary goal of BTCRC-AML17-113, “Phase Ib study of the safety and efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in patients with relapsed or refractory CD33+ acute myeloid leukemia,” is to find the maximum tolerated dose of venetoclax when combined with gemtuzumab ozogamicin. Read More

September 25, 2020:

Researchers at Penn State University are leading a multi-center phase II Big Ten Cancer Research Consortium study for adults with previously untreated, locally advanced pancreatic cancer that tests liposomal irinotecan in combination with FOLFOX, a chemotherapy regimen that includes oxaliplatin, leucovorin, and 5-fluorouracil.

Researchers hope to determine the disease control rate of this combination — the percentage of patients whose tumors respond to treatment or remain stable. The study could help determine if this novel approach could be used as a first-line treatment for locally advanced pancreatic cancer.

Liposomal irinotecan uses a tiny bubble called a liposome that is made of the same material as a cell wall. The liposome is filled with a drug called irinotecan that will circulate through a subject’s body for an extended period, which may result in a longer treatment effect and may help minimize harmful side effects of the drug on healthy tissue. Read More

September 24, 2020:

In this month’s Across the Consortium, the Big Ten Cancer Research Consortium (Big Ten CRC) highlights a variety of activities and accomplishments across universities. From new cancer drugs, to grant awards and new methods of treatments, researchers stop at nothing to continue to fight against cancer. Read More

September 9, 2020:

This month, the Big Ten Cancer Research Consortium highlights the University of Wisconsin Carbone Cancer Center as our featured member. UW Carbone member Elisavet Paplomata, MD, an assistant professor in the Department of Medicine, shares her research interests and expertise in breast and gynecologic cancers in this story, originally published by uwhealth.org.

At the Intersection of Breast and Gynecologic Cancers: Dr. Elisavet Paplomata

Although gynecologic cancers are less common than breast cancer, the treatment of these cancers can be more challenging due to lack of effective screening and subsequent diagnosis at an advanced stage.

New UW Carbone Cancer Center member Elisavet Paplomata, MD, an assistant professor in the Department of Medicine, brings extensive clinical research experience in studying both breast and gynecologic cancers to UW-Madison. Her work focuses on finding new drug treatment options for women diagnosed with these diseases. Read More

August 19, 2020:

In this month’s Across the Consortium, the Big Ten Cancer Research Consortium (Big Ten CRC) highlights investigators focusing on breast cancer research and recent grants awarded to researchers and cancer centers across the Big Ten CRC. Read More

August 1, 2020:

This month, the Big Ten Cancer Research Consortium highlights Masonic Cancer Center, University of Minnesota, as our featured member. Veronika Bachanova, MD, PhD, shares her research interests, and Jeffrey Miller, MD, discusses his research in natural killer (NK) cells.

Investigator Spotlight

Veronika Bachanova, MD, PhD, professor of medicine, Masonic Cancer Center, University of Minnesota Medical School

Educational background

• Medical School: Komenius University, Bratislava, Slovakia
• Residency: Henry Ford Hospital, Detroit, Mich.
• Fellowship: University of Minnesota, Minneapolis, Minn.

Research interests

I am a professor of medicine at the University of Minnesota, section head of hematologic malignancy, and lead for CAR-T Cell Therapy in the Bone Marrow Transplant Program at University of Minnesota. My research and clinical work is focused on immunotherapies and stem cell transplantation for hematologic malignancies, particularly lymphoma. I founded and currently chair the Hematologic Malignancy Tissue Bank and have designed and conducted dozens of investigator-initiated clinical trials for lymphoma and leukemia. Read More

July 13, 2020:

In this month’s Across the Consortium, the Big Ten Cancer Research Consortium (Big Ten CRC) highlights research on disparities when treating and diagnosing cancers, developments in cellular, genomic research, blood diseases, and big data, and ongoing growth at member cancer centers. Read More