E-Newsletter - December 2016

Recent Alliance protocol activations

A011502: A randomized phase III double blinded placebo controlled trial of aspirin as adjuvant therapy for node-positive HER2 negative breast cancer: The ABC trial

Overview: This Alliance trial will study how well aspirin works in preventing the cancer from coming back in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.
Study Chair: Wendy Y. Chen, MD, MPH
E-mail: Wendy_chen@dfci.harvard.edu
Activated: 12/08/16
Link: https://clinicaltrials.gov/show/NCT02927249

A021501: Preoperative extended chemotherapy vs. chemotherapy plus hypofractionated radiation therapy for borderline resectable adenocarcinoma of the head of the pancreas

Overview: This randomized phase II trial will study how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.
Study Chair: Matthew Katz, MD, FACS
E-mail: mhgkatz@mdanderson.org
Activated: 12/01/16
Link: https://clinicaltrials.gov/ct2/show/NCT02839343

#A011401: Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early breast cancer

Overview: This trial will study whether weight loss in overweight and obese women may prevent breast cancer recurrence. Previous studies have found that women who are overweight or obese when their breast cancer is diagnosed have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment. About 3,136 women will take part in this study.

Study Chair: Jennifer Ligibel, MD
E-mail: jligibel@partners.org
Activated: 08/29/16
Link: https://clinicaltrials.gov/ct2/show/NCT02750826

A051301: A randomized double-blind phase III study of ibrutinib during and following autologous stem cell transplantation versus placebo in patients with relapsed or refractory diffuse large b-cell lymphoma of the activated b-cell subtype

Overview: This trial will study ibrutinib to see how well it works compared to placebo when given before and after stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Before transplant, stem cells are taken from patients and stored. Patients then receive high doses of chemotherapy to kill cancer cells and make room for healthy cells. After treatment, the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Ibrutinib is a drug that may stop the growth of cancer cells by blocking a protein that is needed for cell growth. It is not yet known whether adding ibrutinib to chemotherapy before and after stem cell transplant may help the transplant work better in patients with relapsed or refractory diffuse large B-cell lymphoma. About 296 people with activated B-cell (ABC) subtype DLBCL will take part in this study.

Study Chair: Charalambos Andreadis, MD, MSCE
E-mail: candreadis@medicine.ucsf.edu
Activated: 07/06/16
Link: https://clinicaltrials.gov/ct2/show/NCT02443077

Alliance A091404: A phase II study of enzalutamide (NSC #766085) for patients with androgen receptor positive salivary cancers

Overview: This study will test the effects of the study drug, enzalutamide, in patients with salivary gland cancer that cannot be removed with surgery or has spread. Most patients are usually treated with either surgery, radiation, chemotherapy or with other drugs. There are no drugs approved by the U.S. Food and Drug Administration for salivary gland cancer. Although enzalutamide is not FDA-approved to treat salivary gland cancer, it has already been FDA-approved to treat other cancers. Enzalutamide could shrink the cancer but it could also cause side effects. Alliance researchers hope to learn if the study drug will shrink the cancer by at least 30 percent compared to its present size, in at least 1 out of 5 patients. About 45 people will take part in this study.

In this study, Alliance researchers also seek to learn if a biomarker test is helpful in deciding who should be enrolled. The biomarker test will be used to determine if the tumor contains an androgen receptor, which is a protein that responds to a type of hormone that is found in some patients salivary gland tumors. Enzalutamide acts on the androgen receptor, blocking its signals, and thereby possibly causing cancers to shrink.  Tumors removed from patients will be tested for the biomarker test. It is not known if using the biomarker test is better, the same, or worse than if the cancer is treated without using the biomarker test.

Study Chair: Alan Ho, MD, PhD, Memorial Sloan Kettering Cancer Center
E-mail: hoa@mskcc.org
Activated:  06/01/16
Link: https://clinicaltrials.gov/ct2/show/NCT02749903

A221208: Randomized phase II study: Corticosteroids + bevacizumab vs. corticosteroids + placebo (BeST) for radionecrosis after radiosurgery for brain metastases

Overview: This Alliance trial will study how well corticosteroids and bevacizumab work compared to corticosteroids alone in improving symptoms in patients with radionecrosis after radiation surgery for cancer that has spread from the original tumor to the brain. Brain radionecrosis is a non-cancerous condition in which an area of dead tissue in the brain, caused by treatment with radiation therapy, is surrounded by inflamed (swollen) tissue. Brain radionecrosis can cause headaches, nausea, vomiting, weakness and other neurological symptoms. Corticosteroids, drugs given to reduce inflammation, or swelling, are the most common treatment for brain radionecrosis. Bevacizumab may help reduce inflammation and lessen the symptoms of radionecrosis by reducing leaking of the blood vessels. It is not yet known whether giving corticosteroids alone or with bevacizumab is more effective in treating radionecrosis in patients with brain metastasis.
Study Chair: Caroline Chung, MD
E-mail: cchung3@mdanderson.org
Activated: 04/29/16
Link: https://clinicaltrials.gov/show/NCT02490878

For other articles in the December issue of the Alliance E-News newsletter, see below.