Hoosier Cancer Research Network (HCRN) announces the opening of a study for patients with advanced renal cell carcinoma who have not received prior treatment for their kidney cancer.

The phase II clinical trial, known as HCRN GU16-260, involves front-line therapy with nivolumab and salvage therapy with nivolumab and ipilimumab. The study may help researchers determine the activity of nivolumab, an agent already approved for patients with previously treated kidney cancer, in patients who have not received prior treatment.

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A new Hoosier Cancer Research Network study may help researchers learn whether the order in which two drugs are given has any effect on progression-free survival — the length of time it takes for cancer to grow or spread.

The randomized phase II study, known as HCRN GU15-223, will compare overall progression-free survival for two groups of subjects with metastatic renal cell carcinoma (kidney cancer). One group will receive first-line sunitinib, an anti-angiogenic drug, followed by second-line avelumab, an investigational immunotherapy drug. The other group will receive first-line avelumab followed by second-line sunitinib. Patients will have an equal chance of being randomized to either group.

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Abstracts from three Hoosier Cancer Research Network studies were accepted to the American Society of Clinical Oncology (ASCO) 2017 Annual Meeting, June 2-6 at the McCormick Place in Chicago. The studies include LUN14-179 (poster session and discussion), GU14-206 (poster session and discussion), and GI14-186 (poster session). Read More

Hepatocellular carcinoma is an aggressive cancer that is often difficult to treat due to the typical accompanying diagnosis of cirrhosis. For patients who qualify for curative treatment, surgery and liver transplant may be considered. However, most patients are not eligible for curative therapy, and instead may be offered liver-directed or systemic therapies that may extend overall survival, but outcomes remain poor for these patients.

A new Hoosier Cancer Research Network study led by researchers at the University of North Carolina Lineberger Comprehensive Cancer Center will help determine whether adding an immunotherapy drug to standard local radiation therapy for patients with high-risk hepatocellular carcinoma could lead to further improvements in overall survival.

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Three Hoosier Cancer Research Network studies were featured in poster sessions during the 2017 Gastrointestinal Cancers Symposium, Feb. 16-18 in Orlando.

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A new study led by researchers at the Indiana University Melvin and Bren Simon Cancer Center may help answer questions about the role of immunotherapy in combination with chemotherapy in treating lung cancer patients whose disease did not response to immunotherapy.

The randomized phase II study, known as HCRN LUN15-233, involves chemotherapy with or without nivolumab.

The study is now open to accrual at the Indiana University Melvin and Bren Simon Cancer Center. Additional sites will open the study in the near future. Nasser Hanna, MD, is leading the study, along with co-investigators Greg Durm, MD; Laura Lourdes, MD; Shadia Jalal, MD; Lawrence Einhorn, MD; and Adam Miller, MD. Read More

OncoGenex Pharmaceuticals, Inc. has announced positive survival results from the final analysis of the Phase 2 Borealis-2™ trial of apatorsen in combination with docetaxel treatment that enrolled 200 patients with metastatic bladder cancer whose disease had progressed following first-line platinum-based chemotherapy. The trial, also known as HCRN GU12-160, was conducted by the Hoosier Cancer Research Network at 28 sites across the United States.

Patients who received apatorsen treatment experienced a 20 percent reduction in risk of death, compared to patients receiving docetaxel alone (HR=.80; 80% CI: 0.65-0.98; p=0.078). The primary analysis was a superiority test of overall survival, performed at a one-sided 0.10 significance level using a stratified log-rank test.

Read more at oncogenex.com. Read More

A new Hoosier Cancer Research Network study is evaluating whether ginseng can help lessen fatigue in patients treated with regorafenib.

The study, known as GI14-191, builds on earlier research that showed daily use of American ginseng significantly decreased the level of fatigue experienced by cancer patients undergoing treatment. GI14-191 focuses on patients receiving regorafenib for colorectal cancer. The study is currently open to accrual at Wake Forest Baptist Health in Winston-Salem, N.C., with additional sites expected to open in the near future. Read More

Hoosier Cancer Research Network (HCRN) announces the launch of a cancer clinical trial for subjects with newly diagnosed metastatic prostate cancer with bone metastases.

The study, known as GU13-170, will compare the good and bad effects of adding Radium-223 dichloride, a bone-targeted drug, to androgen deprivation therapy, the usual treatment for this type of cancer.

The study is now open to accrual at the University of Michigan Comprehensive Cancer Center. Subjects who enroll on this study will be randomized by chance to one of two groups. The first group, called Arm A, will receive androgen deprivation therapy with bicalutamide. This is the usual treatment. The second group, called Arm B, will receive androgen deprivation therapy with bicalutamide plus the study drug, Radium-223 dichloride. Read More

Hoosier Cancer Research Network (HCRN) recently launched a cancer clinical trial evaluating the efficacy of the PDL-1 inhibiting drug pembrolizumab in the treatment of patients with incurable platinum refractory germ cell tumors.

The study, known as HCRN GU14-206, is now open to accrual at the Indiana University Melvin and Bren Simon Cancer Center. This is a single arm study in which all subjects will receive the study drug, pembrolizumab.

Men and women age 18 and older who have incurable platinum refractory germ cell tumors (testicular or ovarian) may be eligible for this study. Other criteria must be met to fulfill eligibility requirements. Read More

Abstracts from four Hoosier Cancer Research Network studies were accepted to the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting, June 3-7 at the McCormick Place in Chicago. The studies include GU12-157 (poster session), GU14-188 (poster session), GU14-202 (poster session), and LUN14-179 (publication-only abstract). Read More

Hoosier Cancer Research Network is pleased to announce the opening of a cancer clinical trial for subjects with metastatic castrate-resistant prostate cancer at select sites throughout the United States.

The study, known as GU14-202, is designed to assess the safety and toxicity of an investigational drug called niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, given in combination with an anti-androgen drug called enzalutamide. The FDA approved enzalutamide for the treatment of castrate-resistant prostate cancer in 2012, but it has not yet approved niraparib.

PARP is a group of proteins that are involved with DNA repair. According to study co-investigator John Paul Flores, MD, of Tufts Medical Center, castrate-resistant prostate cancer often involves defects in DNA repair. Read More

A new Hoosier Cancer Research Network study is exploring the effects of pembrolizumab in treating metastatic urothelial cancer. The study, known as GU14-182, will compare maintenance pembrolizumab to a placebo in subjects after first-line chemotherapy for metastatic urothelial cancer (e.g., cancer of the bladder, urethra, ureter, or renal pelvis).

The study is currently open to accrual at the Tisch Cancer Institute at Mount Sinai.

The standard approach to treating metastatic urothelial cancer is chemotherapy administered for about 4-6 cycles. If the disease has stabilized or responded, treatment is usually stopped and patients are monitored until their cancer starts to grow again. This is the standard approach because continuing additional standard chemotherapy usually leads to an increase in side effects without necessarily improving the results achieved with chemotherapy. GU14-182 will test whether or not this “stop and wait” approach can be improved by administering pembrolizumab following chemotherapy, according to the study’s sponsor investigator, Matthew Galsky, MD, director of genitourinary medical oncology at the Tisch Cancer Institute at Mount Sinai. Read More

In an oral abstract session at the 2016 Genitourinary Cancers Symposium, Matthew Galsky, MD, reported on the HCRN GU10-148 study, a phase II trial of gemcitabine and cisplatin plus ipilimumab as first-line treatment for patients with metastatic urothelial carcinoma. Dr. Galsky (pictured), of the Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, is sponsor-investigator of the multi-center trial. Read More

In a new journal article published online ahead of print in Supportive Care in Cancer, Hoosier Cancer Research Network investigators reported on results of QL12-153, a phase II study of fosaprepitant + 5HT3 receptor agonist + dexamethasone in patients with germ cell tumors undergoing 5-day cisplatin-based chemotherapy. The multi-center study was led by sponsor investigator Lawrence H. Einhorn (pictured), of the Indiana University School of Medicine. Read More

Hoosier Cancer Research Network recently opened a cancer clinical trial for subjects with advanced colorectal cancer. The study, known as GI14-186, involves the study drug called pembrolizumab, given in combination with mFOLFOX6, a standard chemotherapy regimen for advanced colorectal cancer. The study is currently open to accrual at the Indiana University Melvin and Bren Simon Cancer Center, The Ohio State University, and Winship Cancer Institute of Emory University.

Cancer cells often create proteins called PD-1 that act as signals to turn off part of the immune system that recognizes cancer as foreign. Pembrolizumab blocks this signal and allows the immune system to recognize and attack these cancer cells.

The use of pembrolizumab in combination with mFOLFOX6 is investigational. This means that the FDA has not approved this combination of drugs for this type of cancer. This study will allow researchers to know whether adding pembrolizumab to the usual chemotherapy drugs makes the treatment work better, the same, or worse than the usual approach.

Participants in this study must have advanced colorectal cancer, and have not had prior systemic therapy for advanced or metastatic disease. Additional criteria must be met to be eligible for this study. Read More

Hoosier Cancer Research Network recently launched a Symptom Management Clinical Trial Working Group. The group grew out of a desire to see improvements in quality of life for patients, from diagnosis through survivorship.

Formation of the group was sparked by Julie Otte, PhD, RN, OCN from the Indiana University School of Nursing and her commitment to enhancing the patient experience. “It’s one thing to do this great research, but it has to be something that eventually makes it to the patient,” said Otte, co-chair of the group. Read More

OncoGenex Pharmaceuticals, Inc., recently announced that Borealis-2™, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy, Borealis-2 is managed by Hoosier Cancer Research Network and is being conducted at 27 sites across the United States. The sponsor investigator is Noah Hahn, MD, associate professor of oncology and urology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine.

Patients enrolled in Borealis-2 were randomized to receive either apatorsen plus docetaxel or doecetaxel alone. Patients could continue weekly apatorsen infusions as maintenance treatment until disease progression or unacceptable toxicity if they completed all 10 planned cycles of docetaxel or discontinued from docetaxel due to toxicity. Evaluation of overall survival is the primary study objective. Read More

A new journal article on Hoosier Cancer Research Network’s GU07-122 study will appear in the October 2015 issue of Urologic Oncology. The study was designed to determine feasibility and safety of treatment with dasatinib administered orally once daily for 4 weeks duration prior to radical cystectomy for urothelial carcinoma of the bladder. Read More

The Bladder Cancer Advocacy Network (BCAN) and Paradigm today announced a partnership for the launch of a large-scale genomically-driven bladder cancer study. Hoosier Cancer Research Network (HCRN) will act as the coordinating center.

This prospective study is the first project of the Bladder Cancer Genomics Consortium (BCGC), a collaborative effort between BCAN and major medical centers. The BCGC’s goal is to develop an enriched understanding of the genomic profile of bladder cancer to facilitate the development of novel therapeutics. Bladder cancer is the fifth most commonly diagnosed cancer in the U.S., with nearly 75,000 new cases and 16,000 deaths in 2015. Read More