Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
Start Date
12/24/2020
Completion Date
2/1/2029
Summary
This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.
Detailed Description
This is a phase II, open-label, non-randomized, multi-institutional study investigating postoperative or adjuvant human epidermal growth factor receptor (HER2)-directed therapy with adjuvant ado-trastuzumab emtansine (T-DM1) in HER2-positive salivary gland carcinomas (SGC). This research study is: * Studying the use of T-DM1 in combination with radiation and chemotherapy; and the use of maintenance T-DM1 alone for up to a year after surgery * Evaluating the effectiveness, safety, and toxicity of T-DM1 T-DM1 is a specialized antibody targeting HER-2 (a protein that is expressed in some breast and salivary gland cancers). The drug is a HER-2 antibody that is bound to a chemotherapy agent (DM1) and delivered intravenously. T-DM1 then binds cancer cells that express HER-2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way. This allows the use of a targeted treatment along with chemoradiation to treat HER-2 expressing salivary cancers. The U.S. Food and Drug Administration (FDA) has not approved T-DM1 for HER2-positive salivary gland cancer but it has been approved for other uses (for breast cancers that express HER2 protein). The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. This research study involves radiation, chemotherapy, and targeted therapy given after surgery for up to 1-year, and participants will be followed for 3 years. It is expected that about 55 people will take part in this research study. Genentech is supporting this research study by providing the research study drug, T-DM1.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Ado-trastuzumab (T) emtansine (T-DM1)
Standard of Care Radiotherapy
Standard of Care Chemotherapy
Conditions
Locations
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
University of Chicago
Chicago, Illinois 60637
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
University of Washington Medical Center
Seattle, Washington 98195
United States