A Phase I Study of M6620 (VX-970, Berzosertib) in Combination With Cisplatin and XRT in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121)

Who is this study for? Adult patients with Stage III to IV Head and Neck Squamous Cell Carcinoma that are not eligible for surgical resection
Status: Active_not_recruiting
Location: See all (19) locations...
Intervention Type: Procedure, Drug, Other, Radiation
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This phase I trial studies the side effects and best dose of berzosertib (M6620) when given together with cisplatin and radiation therapy in treating patients with head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes (locally advanced). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as cisplatin, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving M6620 together with cisplatin and radiation therapy may work better in treating patients with locally advanced head and neck squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have histologically or cytologically confirmed head and neck squamous cell cancer (HNSCC) including paranasal sinus cancers but excluding nasopharyngeal carcinomas

• Clinical staged III or IV HNSCC, according to American Joint Committee on Cancer (AJCC) 7th Edition, that is not amenable to surgical resection

• Carcinoma of the neck of unknown primary site origin (regardless of HPV/p16 status) is eligible

• Age \>= 18 years; because no dosing or adverse event data are currently available on the use of M6620 (VX-970, berzosertib) in combination with cisplatin in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials

• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)

• Life expectancy of greater than 3 months

• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm (\>= 2 cm) with conventional techniques or as \>= 10 mm (\>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam

• Leukocytes \>= 3,000/mcL

• Absolute neutrophil count \>= 1,500/mcL

• Platelets \>= 100,000/mcL

• Total bilirubin within normal institutional limits

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal

• Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal

• The effects of M6620 (VX-970, berzosertib) on the developing human fetus are unknown; for this reason and because DNA-damage response (DDR) inhibitors as well as other therapeutic agents used in this trial may have teratogenic potential, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of M6620 (VX-970, berzosertib) administration

• Ability to understand and the willingness to sign a written informed consent document

• Women of childbearing potential who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for up to 6 months following the last administration of study treatment; men who are sexually active must be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and for 6 months after completion of M6620 (VX-970, berzosertib) administration

Locations
United States
California
City of Hope Comprehensive Cancer Center
Duarte
University of California Davis Comprehensive Cancer Center
Sacramento
Connecticut
Smilow Cancer Center/Yale-New Haven Hospital
New Haven
Yale University
New Haven
Smilow Cancer Hospital Care Center-Trumbull
Trumbull
Georgia
Emory University Hospital Midtown
Atlanta
Emory University Hospital/Winship Cancer Institute
Atlanta
Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
University of Maryland/Greenebaum Cancer Center
Baltimore
Michigan
Wayne State University/Karmanos Cancer Institute
Detroit
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
Ohio
Case Western Reserve University
Cleveland
Ohio State University Comprehensive Cancer Center
Columbus
Pennsylvania
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
Virginia
University of Virginia Cancer Center
Charlottesville
Wisconsin
University of Wisconsin Carbone Cancer Center - University Hospital
Madison
Time Frame
Start Date: 2017-04-17
Completion Date: 2025-04-23
Participants
Target number of participants: 43
Treatments
Experimental: Treatment (berzosertib, cisplatin, radiation therapy)
Patients receive berzosertib IV over 60 minutes on day -7 and then weekly on day 2 and cisplatin IV over 30-60 minutes weekly on day 1. Patients also undergo radiation therapy once daily, 5 days a week. Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT, PET/CT, or MRI throughout the study.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials