A Phase II Study of Repeat Intranodal Injections of Adenovirus-CD 154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma
This is a phase II clinical trial in which study subjects will be treated with multiple
doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35
viral particles. Intranodal injections will be administered every 2-4 weeks up to six total
Because this is the first time that repeat administration of Ad-ISF35 will be performed via
intranodal injection, and in order to allow sufficient time to evaluate the safety and
toxicity of this procedure, we will treat subjects 1 thru 3 at one month intervals and with
inpatient admission for 24 hours observation. After subject three receives their second
ISF35 injection we will proceed with enrollment of cohorts of four patients per month at one
week intervals until study enrollment has been completed. These subjects will be treated as
outpatients and will be observed for 3 hours prior to discharge.
ISF35 has already been used in Phase I clinical trials. The trials demonstrated that ISF35
treatment is well-tolerated and patients did not experience any significant or unexpected
adverse events. Patients reported flu-like symptoms from ISF35, which disappeared within one
to three days.
ISF35 is an abbreviation for Immune Stimulatory Factor 35, an offspring of technology
discovered by Dr. Thomas J. Kipps, MD, PhD, Professor, Department of Medicine and Deputy
Director for Research,UCSD Moores Cancer Center.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine and monitor clinical and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.
2 years (evaluation will be approx. 4 months per patient)
Januario Castro, M.D.
Associate Clinical Professor in the Blood and Marrow Transplantation Division
United States: Food and Drug Administration
UCSD-101357 - prev 080497
|University of California, San Diego Moores Cancer Center||San Diego, California 92093|