Study of Repeat Intranodal Injections of Ad-ISF35
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00942409|
Recruitment Status : Terminated (drug supply was no longer available)
First Posted : July 20, 2009
Results First Posted : November 20, 2015
Last Update Posted : December 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Follicular Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia||Biological: ISF35||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2014|
Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
Subjects participating in this study 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.
- Overall Response Rate [ Time Frame: 2 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942409
|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|