A Phase II Study of Repeat Intranodal Injections of Adenovirus-CD154 (Ad-ISF35) in Patients With Non-Hodgkin's Lymphoma (Follicular, Diffuse Large Cell, Mantle Cell and Small Lymphocytic Lymphoma/Chronic Lymphocytic Leukemia)
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
This will be the first time that repeat administration of Ad-ISF35 will be performed via
intranodal injection in subjects with a diagnosis other than CLL/SLL. Therefore, in order
to allow sufficient time to evaluate the safety and toxicity of this procedure in
non-CLL/SLL patients, we will treat the first three non-CLL/SLL subjects with inpatient
admission for 24 hours observation at the GCRC-UCSD. If no serious adverse events are
observed in these first three patients after they have received their first two injections
of ISF35 and have been observed for at least 28 days, then we will proceed with enrollment
of cohorts of four subjects per month. This will be done at one week intervals until study
enrollment is completed. These subjects will be treated as outpatients at the GCRC and
observed for 3 hours prior to discharge.
All subjects with a diagnosis of CLL or SLL will be treated as outpatients at the GCRC and
observed for 3 hours prior to discharge. These subjects will not need to be treated in an
inpatient setting, based on our previous clinical experience with subjects enrolled on the
phase II study of repeat intranodal injections of Ad-ISF35 in CLL/SLL
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 biological responses in patients with NHL including follicular lymphoma, diffuse large cell lymphoma, mantle cell lymphoma and SLL/CLL 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 Bone Marrow Transplantation Division
United States: Food and Drug Administration
UCSD-101358 - prev 081503
|University of California, San Diego Moores Cancer Center||San Diego, California 92093|