A Phase II, Multicenter, Open Label Study to Evaluate Effectiveness and Safety of AdCMV-p53 Administered by Intra-Tumoral Injections in 39 Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
OBJECTIVES: I. Estimate the objective response rate of Ad5CMV-p53 in patients with recurrent
squamous cell carcinoma of the head and neck. II. Evaluate the duration of response, time to
disease progression, and overall survival of these patients after this treatment. III.
Evaluate the effectiveness of Ad5CMV-p53 in reducing cancer morbidity (pain assessment,
analgesic consumption, and Karnofsky performance status). IV. Assess the quality of life of
these patients receiving this treatment.
OUTLINE: This is a multicenter, open label study. All patients receive direct intratumoral
injections of Ad5CMV-p53 on days 1, 2, and 3 of each 4-week treatment course. Patients are
treated for at least 2 courses barring local disease progression or unacceptable adverse
events; patients with responding or stable disease receive a maximum of 12 courses. Patients
are evaluated for safety 4 weeks from the completion of the last treatment. Quality of life
is assessed before, during, and after treatment. Patients are followed every 2 months for up
to 18 months or until death.
PROJECTED ACCRUAL: A maximum of 39 patients will be accrued for this study.
Primary Purpose: Treatment
Lyndah Dreiling, MD
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|University of Colorado Cancer Center||Denver, Colorado 80262|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|
|Tulane University School of Medicine||New Orleans, Louisiana 70112|
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Sidney Kimmel Cancer Center||San Diego, California 92121|
|Clinical Sciences Building||Chicago, Illinois 60612|
|University of Connecticut School of Medicine||Farmington, Connecticut 06032|