NCT00038415

A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: 1. To determine if patients with Binet Stage A CLL generate an immune response to an antigen delivered by a DNA vaccine. 2. To determine if patients with Binet Stage A CLL generate an immune response to a tumor derived antigen delivered by a DNA vaccine. 3. To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses. 4. To characterize any adverse effects of idiotypic vaccination with a DNA vaccine. 5. To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s Stage A CLL.

Conditions

• Leukemia, Lymphocytic, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	CLL vaccine using DNA plasmid vector

Timeline

• Start date: 2001-12-01
• Primary completion: 2004-07-01
• Completion: 2005-01-01
• First posted: 2002-05-31
• Last updated: 2018-10-31

Locations

1 site across 1 country: United States