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Sponsors and Collaborators: |
Memgen, LLC University of California, San Diego |
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Information provided by: | Memgen, LLC |
ClinicalTrials.gov Identifier: | NCT00783874 |
This is a phase I, open label, non-randomized, single institution based clinical trial. Eligible subjects will receive a single dose of Ad-ISF35 injected directly into a selected lymph node under ultrasound guidance. The primary goal of this trial is to determine the maximum tolerated dose (MTD) of intranodal injection of Ad-ISF35.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
Biological: ISF35 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I, Open Label, Dose Escalation, Pharmacodynamic Study of Intranodal Injection of Adenovirus-CD154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. |
Enrollment: | 15 |
Study Start Date: | September 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
We will use a 3+3 dose escalation scheme with the following doses of Ad-ISF35:
Cohort # 1 1 x 10^10 viral particles (vp)
Cohort # 2 3 x 10^10 vp
Cohort # 3 1 x 10^11 vp
Cohort # 4 3 x 10^11 vp
The concentration of the viral preparation will be 5 x 10^11 vp/ml. Based on plaque forming unit (pfu) assays we have observed that approximately 20 viral particles are equivalent to 1 pfu. Dose escalations will occur after the patient(s) assigned to the prior dose level has been observed for 21 days after injection of ISF35. The recommended Phase II dose is expected to be the highest dose below the maximally tolerated dose (MTD) at which ≤1/6 patients experience dose-limiting toxicity (DLT) during the first 21 days of treatment. However, the final determination will also take into account any cumulative or delayed toxicity.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosis of B-cell CLL/SLL including
Indication for treatment as defined by the NCI Working Group Guidelines:
Laboratory parameters as specified below:
Exclusion Criteria:
United States, California | |
University of California, San Diego Moores Cancer Center | |
San Diego, California, United States |
Principal Investigator: | Januario Castro, MD | Assistant Clinical Professor in the Blood and Marrow Transplantation Division |
Principal Investigator: | Thomas J Kipps, MD, PhD | Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research in the UCSD School of Medicine |
Responsible Party: | University of California, San Diego Moores Cancer Center ( Dr. Januario Castro, M.D./Assistant Clinical Professor in the Blood and Marrow Transplantation Division ) |
Study ID Numbers: | CLL-35-201 |
Study First Received: | October 31, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00783874 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Chronic lymphocytic leukemia Small Lymphocytic Lymphoma Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Immune System Diseases |
ISF35 Ad-ISF35 CLL SLL non-Hodgkin's lymphoma NHL |
Leukemia, Lymphoid Immunoproliferative Disorders Adenoviridae Infections Lymphoma, Small Cleaved-cell, Diffuse Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia |
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Lymphoma |
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Leukemia, Lymphocytic, Chronic, B-Cell Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma |