Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04620187
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • HER2 Gene Mutation
  • Salivary Gland Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ado-trastuzumab (T) emtansine (T-DM1) — DRUG
    Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)
  • Standard of Care Radiotherapy — RADIATION
    Radiotherapy to shrink or kill tumors
  • Standard of Care Chemotherapy — DRUG
    Intravenous injection

Study Details

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.

Key Dates

Start date
Dec 24, 2020
Status verified
Apr 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer
    Participants will undergo standard of care surgery followed by standard of care radiation and chemotherapy with the addition of T-DM1. Study cycles are 21 days (3 weeks): * Participants will be given the study treatment T-DM1 at a predetermined dose (3.6 mg/kg) intravenously once (1x) every 3 weeks for up to 52 weeks (or about 1 year). * Participants will be given standard of care radiation and chemotherapy * Radiation will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1 * Chemotherapy (cisplatin 40 mg/m2 intravenously or carboplatin AUC 2 intravenously) will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1 Participants will be followed for 2 years.

Primary Outcome Measure

2 Year Disease-free survival (DFS) Rate [ Time Frame: Time from the date of study registration to first invasive local, regional, distant recurrence, or death due to any cause assessed up to 36 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322
Conor Steuer, MD
[email protected]
404-778-5378
University of ChicagoChicagoIllinois60637
Alexander T Pearson, MD, PhD
[email protected]
855-702-8222
Cancer Clinical Trials Office
[email protected]
855-702-8222
Alexander T Pearson, MD, PhD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Glenn J Hanna, MD
[email protected]
617-632-3090
Glenn J Hanna, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Glenn J. Hanna, MD
[email protected]
617-632-3090
Glenn J. Hanna, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920
Alan L Ho, MD, PhD
833-637-1274
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748
Alan L Ho, MD, PhD
844-665-7394
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering BergenMontvaleNew Jersey07645
Alan L Ho, MD, PhD
551-751-1007
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering CommackCommackNew York11725
Alan L Ho, MD, PhD
833-637-1274
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Alan L Ho, MD, PhD
914-893-4461
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10021
Alan L Ho, MD, PhD
833-637-1274
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alan L Ho, MD, PhD
646-733-4430
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering NassauUniondaleNew York11553
Alan L Ho, MD, PhD
516-564-2022
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
Jay Liao, MD
Jay Liao, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Winship Cancer Institute, Emory University· Atlanta, GAUniversity of Chicago· Chicago, ILBrigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJ

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