E-Newsletter - December 2019
Spotlight on Alliance Trials

 

The Alliance for Clinical Trials in Oncology activated 14 new cancer clinical trials in 2019. Listed below are these trials, which are currently enrolling patients.

Take a look.

Alliance A031801: A phase II randomized trial of radium-223 dichloride and cabozantinib in patients with advanced renal cell carcinoma with bone metastasis (RadiCal)

Overview: This phase II Alliance trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone.

Study Chair: Rana R. McKay, MD, University of California San Diego
E-mail: rmckay@ucsd.edu
Activated: 12/13/19
CT.gov Link: http://bit.ly/AllianceA031801

Alliance A071801: Phase III trial of post-surgical single fraction stereotactic radiosurgery (SRS) compared with fractionated SRS (FSRS) for resected metastatic brain disease

Overview: This phase III Alliance trial looks to see how well single-fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single-fraction stereotactic radiosurgery.

Study Chair: Paul Brown, MD, Mayo Clinic
E-mail: brown.paul@mayo.edu
Activated: 10/11/19
CT.gov Link: http://bit.ly/AllianceA071801

Alliance A021703: Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)

Overview: This phase III Alliance trial looks at how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).

Study Chair: Kimmie Ng, MD, Dana-Farber Cancer Institute
E-mail: kng4@partners.org
Activated: 9/30/19
CT.gov Link: http://bit.ly/AllianceA021703

Alliance A071701: Genomically-guided treatment trial in brain metastases

Overview: This phase II Alliance trial looks at how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.

Study Chair: Priscilla Brastianos, MD, Massachusetts General Hospital
E-mail: pbrastianos@partners.org
Activated: 8/15/19
Link: http://bit.ly/AllianceA071701

Alliance A051701: Randomized phase II/III study of venetoclax (ABT199) plus dose-adjusted EPOCH-R for MYC/BCL2 double-hit and double protein expressing lymphomas

Overview: This phase II/III Alliance trial looks at whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax, to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.

Study chair: Jeremy Abramson, MD, Massachusetts General Hospital Cancer Center
E-mail: jabramson@mgh.harvard.edu
Activated: 8/7/19
Link: http://bit.ly/AllianceA051701

Alliance A221702: Axillary Reverse Mapping: A prospective trial to study rates of lymphedema and regional recurrence after sentinel lymph node biopsy and sentinel lymph node biopsy followed by axillary lymph node dissection with and without axillary reverse mapping (ARM)

Overview: This phase III Alliance trial looks at how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

Study chair: V. Suzanne Klimberg, MD, PhD, University of Texas Medical Branch at Galveston
E-mail: Vsklimbe@utmb.edu
Activated: 5/31/19
Link: http://bit.ly/AllianceA221702

Alliance A091802: Phase II randomized trial of avelumab plus cetuximab versus avelumab alone in advanced cutaneous squamous cell carcinoma of the skin (cSCC)

Overview: This phase II Alliance trial looks at how well avelumab with or without cetuximab work in treating patients with skin squamous cell cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as avelumab and cetuximab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread.

Study chair: Dan P. Zandberg, MD, University of Pittsburgh Medical Center Hillman Cancer Center
E-mail: zandbergdp@upmc.edu
Activated: 5/17/19
Link: http://bit.ly/AllianceA091802

Alliance A031704 - PD-inhibitor (nivolumab) and ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab: A phase III trial in metastatic untreated renal cell cancer (PDIGREE)

Overview: This phase III Alliance trial looks at how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, 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. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.

Study chair: Tian Zhang, MD - Duke University Medical Center
E-mail: tian.zhang2@dm.duke.edu
Activated: 5/9/19
Link: http://bit.ly/AllianceA031704

Alliance A031702 - Phase II study of cabozantinib in combination with nivolumab and ipilimumab in rare genitourinary tumors

Overview: This phase II Alliance trial looks at how well cabozantinib s-malate, nivolumab, and ipilimumab work together in treating patients with genitourinary tumors that have spread to other places in the body. Cabozantinib s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib s-malate, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib s-malate, nivolumab, or ipilimumab alone.

Study chair: Andrea Apolo, MD - NCI Center for Cancer Research
E-mail: andrea.apolo@nih.gov
Activated: 4/12/19
Link:http://bit.ly/AllianceA031702

Alliance A231601CD - Improving surgical care and outcomes in older cancer patients through implementation of an efficient pre-surgical toolkit (OPTI-Surg)

Overview: This Alliance trial looks at how well the use of a pre-surgical toolkit (OPTI-Surg) works in improving surgical care and outcomes in older participants with cancer. In many elderly patients, surgery can greatly affect physical condition and the ability to return to pre-surgery levels of physical functioning. Providing pre-surgical recommendations may help improve participants' recovery rate and functioning after surgery.

Study Chair: George J. Chang, MD, MS – University of Texas MD Anderson Cancer Center
E-mail: gchang@mdanderson.org
Activated: 4/1/2019
Link: http://bit.ly/AllianceA231601CD

Alliance A231701CD - Increasing socioeconomically disadvantaged patients' engagement in breast cancer surgery decision making through a shared decision making intervention

Overview: This limited access Alliance trial looks at how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by patients who are socioeconomically disadvantaged.

Study Chair: Heather B. Neuman, MD - University of Wisconsin School of Medicine and Public Health
E-mail: neuman@surgery.wisc.edu
Activated: 3/1/2019
Link: http://bit.ly/AllianceA231701CD

Alliance A221701 - Phase III placebo-controlled trial to evaluate dexamethasone use for everolimus-induced oral stomatitis: Prevention versus early treatment approaches

Overview: This Alliance phase III trial looks at how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve the quality of life in cancer patients.

Study Chair: Kathryn J. Ruddy, MD - Mayo Clinic
E-mail: ruddy.kathryn@mayo.edu
Activated: 2/15/2019
Link: http://bit.ly/AllianceA221701

Alliance A041701 - A randomized phase II/III study of conventional chemotherapy +/- uproleselan (GMI-1271) in older adults with acute myeloid leukemia receiving intensive induction chemotherapy

Overview: This Alliance phase II/III trial looks at how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

Study Chair: Geoffrey L. Uy, MD - Washington University - Siteman Cancer Center
E-mail: guy@wustl.edu
Activated: 1/16/2019
Link: http://bit.ly/AllianceA041701

Alliance A041702 - A randomized phase III study of ibrutinib plus obinutuzumab versus ibrutinib plus venetoclax and obinutuzumab in untreated older patients (>70 years of age) with chronic lymphocytic leukemia (CLL)

Overview: This Alliance trial looks at how well ibrutinib and obinutuzumab with or without venetoclax works in treating older patients with untreated chronic lymphocytic leukemia. The drug ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia.

Study Chair: Jennifer Woyach, MD - Ohio State University
E-mail: woyach.2@osu.edu
Activated: 1/4/2019
Link: http://bit.ly/AllianceA041702