Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Non-Hodgkin's Lymphoma (Follicular, Diffuse Large Cell, Mantle Cell, and Small Lymphocytic Lymphoma/Chronic Lymphocytic Leukemia (NHL)
Recruitment status was Active, not recruiting
This is a Phase II, open label, fixed dose, repeat injection, single institution study. Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.
Diffuse Large Cell Lymphoma
Mantle Cell Lymphoma
Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- 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. [ Time Frame: 2 Years (evaluation will be approx. 4 months per patient) ] [ Designated as safety issue: Yes ]
- Determine the safety of repeat administration of Ad-ISF35 injected directly into lymph nodes of patients with NHL including follicular lymphoma, diffuse large cell lymphoma, mantle cell lymphoma and SLL/CLL. [ Time Frame: 2 Years (evaluation will be approximately 1 year per patient) ] [ Designated as safety issue: Yes ]
- Determine pharmacodynamic parameters in patients treated with repeat intranodal injections of Ad-ISF35. [ Time Frame: 2 Years (evaluation will be approximately 4 months per patient) ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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 injections.
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.
|United States, California|
|University of California, San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Januario Castro, M.D.||Associate Clinical Professor in the Blood and Bone Marrow Transplantation Division|
|Principal Investigator:||Thomas J Kipps, M.D., Ph.D.||Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research in the UCSD School of Medicine|