A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
The goal of this clinical research study is learn if a vaccine that contains the patient's own cancer cell immunoglobulin can shrink or slow the growth of Chronic Lymphocytic Leukemia (CLL). This clinical trial is a dose escalation study in which the safety of this vaccine will be studied. This is a dose escalation study in which each patient will receive vaccine at one dose level. Patients will be injected with a fragment of Deoxyribonucleic acid (DNA) containing the sequence of their own immunoglobulin gene. Patients will be required to have their diagnosis of CLL and stage confirmed prior to initiating vaccination. After vaccination patients will receive clinical and immunologic evaluation, including both humoral and cellular responses. The investigator will be assessing the patient's immune response or whether the patient's body recognizes the DNA vaccine. In addition, side effects and reactions to the vaccine will be evaluated.
Leukemia, Lymphocytic, Chronic
Biological: CLL vaccine using DNA plasmid vector
|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 I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach|
- Maximum Tolerated Dose (MTD) [ Time Frame: Continuous reassessment up to 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2001|
|Study Completion Date:||January 2005|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
- To determine if patients with Binet Stage A CLL generate an immune response to an antigen delivered by a DNA vaccine.
- To determine if patients with Binet Stage A CLL generate an immune response to a tumor derived antigen delivered by a DNA vaccine.
- To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses.
- To characterize any adverse effects of idiotypic vaccination with a DNA vaccine.
- To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s Stage A CLL.
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael J. Keating, MD||UT MD Anderson Cancer Center|