A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of the Effects of GC4419 on Severe Oral Mucositis in Patients Receiving Cisplatin + Intensity-modulated Radiation Therapy (IMRT) for Locally Advanced Non-Metastatic Squamous Cell Carcinoma (SCC) of the Oral Cavity/Oropharynx

Status: Completed
Location: See all (64) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Pathologically-confirmed diagnosis of squamous cell carcinoma of the head and neck, defined as SCC of the oral cavity or oropharynx that will be treated with cisplatin plus concurrent IMRT Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criteria #2 and #3 below are eligible for the trial.

• Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 50 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.

• Treatment plan to receive standard cisplatin monotherapy administered either every three weeks (80-100 mg/m2 for 3 doses) or weekly (30-40 mg/m2 for 6-7 doses). The decision on which chemotherapy regimen to use in combination with IMRT and GC4419 will be at the discretion of the investigator.

• Age 18 years or older

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Adequate hematologic function as indicated by:

• Absolute neutrophil counts (ANC) ≥ 1,500/mm3

• Hemoglobin (Hgb) ≥ 9.0 g/dL

• Platelet count ≥ 100,000/mm3

• Adequate renal and liver function as indicated by:

• Serum creatinine acceptable for treatment with cisplatin per institutional guidelines

• Total bilirubin ≤ 1.5 x upper-normal limit (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

• Alkaline phosphatase ≤ 2.5 x ULN

• Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test

• Serum pregnancy test negative for females of childbearing potential

• Males and females must agree to use effective contraception starting prior to the first day of treatment and continuing for 30 days after the last dose of GC4419

• Properly obtained written informed consent

Locations
United States
Arkansas
Fowler Family Center for Cancer Care
Jonesboro
University of Arkansas for Medical Sciences- Winthrop P. Rockefeller Cancer Institute
Little Rock
Arizona
University of Arizona Cancer Center at Dignity Health St. Joseph's
Phoenix
University of Arizona
Tucson
California
VA Long Beach Healthcare System
Long Beach
USC Norris Comprehensive Cancer Center
Los Angeles
Clinical Trials and Research Associates, Inc.
Montebello
UC Irvine Chao Family Comprehensive Cancer Center
Orange
Stanford Cancer Institute
Stanford
Colorado
St. Mary's Regional Cancer Center
Grand Junction
Connecticut
UConn Health School of Dental Medicine
Farmington
Florida
Pasco Pinellas Cancer Center
Holiday
Lakeland Regional Health Cancer Center
Lakeland
UF Health Cancer Center at Orlando Health
Orlando
Sacred Heart Medical Oncology Group
Pensacola
Iowa
Department of Radiation Oncology University of Iowa Hospitals & Clinics
Iowa City
Illinois
Northwestern University
Chicago
Indiana
University of Indianan, Goshen Center for Cancer Care
Goshen
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
Ashland-Bellefonte Cancer Center
Ashland
University of Kentucky, Albert B. Chandler Medical Center
Lexington
University of Louisville Hospital, James Graham Brown Cancer Center
Louisville
Louisiana
Tulane Cancer Center
New Orleans
CHRISTUS Schumpert Cancer Treatment Center
Shreveport
Massachusetts
Baystate Regional Cancer Program
Springfield
Michigan
University of Michigan
Ann Arbor
Henry Ford Allegiance Health
Jackson
Lake Huron Medical Center
Port Huron
Missouri
Ellis Fichel Cancer Center, University of Missouri
Columbia
Montana
Billings Clinic
Billings
St. Vincent Frontier Cancer Center
Billings
North Carolina
East Carolina University, Leo W. Jenkins Cancer Center
Greenville
Marion L. Shepard Cancer Center
Washington
Wake Forest Health
Winston-salem
New Jersey
Hunterdon Hematology Oncology, LLC Hunterdon Regional Cancer Center
Flemington
Jersey Shore University Medical Center- Hackensack Meridian Health
Neptune
Nevada
Renown Cancer Institute
Reno
New York
Montefiore Medical Center
Bronx
Ohio
Ohio State University, James Cancer Center
Columbus
Toledo Clinic Cancer Center
Toledo
Oregon
Oregon Health and Science University
Portland
VA Portland Health Care System
Portland
Pennsylvania
St. Luke's University Health Network
Easton
Thomas-Jefferson University Hospital-Bodine Center for Cancer Treatment
Philadelphia
Allegheny General Hospital, Allegheny Cancer Center
Pittsburgh
Rhode Island
Rhode Island Hospital
Providence
South Carolina
AnMed Health Cancer Center
Anderson
Charleston Cancer Center
Charleston
Spartanburg Medical Center
Spartanburg
South Dakota
Prairie Lakes Health Care System
Watertown
Tennessee
Mountain States Health Alliance
Johnson City
University of Tennessee Medical Center
Knoxville
Texas
Texas Oncology
Plano
Scott and White Memorial Hospital and Clinic
Temple
Hope Cancer Center
Tyler
Vermont
The University of Vermont Medical Center
Burlington
Washington
Providence Regional Medical Center
Everett
VA Puget Sound Health Care System
Seattle
Cancer Care Northwest
Spokane
West Virginia
West Virginia University
Morgantown
Other Locations
Canada
Jewish General Hospital
Montreal
Northeast Cancer Centre, Health Sciences North
Sudbury
Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-centre-du-Québec
Trois-rivières
Puerto Rico
Fundación de Investigación
San Juan
Time Frame
Start Date: October 12, 2015
Completion Date: August 29, 2019
Participants
Target number of participants: 223
Treatments
Experimental: Low Dose GC4419: 30mg/day
30 mg GC4419/day prior to IMRT
Experimental: High Dose GC4419: 90mg/day
90 mg GC4419/day prior to IMRT
Placebo Comparator: Placebo
Placebo daily, prior to IMRT
Authors
Celine Ord, Maria Matsangou, Kyle Colvett, Waqas Rehman, John Thropay, Bipinkumar Amin, Elizabeth Feldman, Mohammed Almubarak, Rex Mowat, Chaitali Nangia, Rajesh Lalla, Ganesh Kudva, Madhavi Venigalla, Maura Barry, Carryn Anderson, Mercedes Porosnicu, Abhinand Peddada, John Holland, C. Daniel Kingsley, Sharon Gordon, Philip Kovoor, Vernon King, Arielle Lee, Tony Quang, Mahesh Kudrimoti, Steven J DiBiase, Kanu Dalal, Charles Holladay, Jorge Nieva, Patrick W Cobb, Leander Cannick, Anshu Jain, Omar Atiq, Joseph Kelley, Sanjiv Agarwala, Francis Worden, Wendy Hara, Steve P Lee, Michael Trendle, James Wheeler, William Wisbeck, Wilson Mertens, Douglas Miller, Ariel Birnbaum, Alan C Gowan, Marcello Bonomi, Amarintha Curtis, Francois Vincent, Scott Boniol, Christopher Lominska, Daniel R Clayburgh, Dukagjin Blakaj, Larissa Greenberg, Bianca deSouza, Neil Dunlap, Kevin Collins, Roberto A Araujo, Pamela Smith, Madhar Garg, Mirelis Acosta Rivera, Deborah Saunders, Voichita Bar-Ad, Christopher Lee, Khalil Sultanem
Sponsors
Leads: Galera Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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