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

Study Overview
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Brief Summary
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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
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OBJECTIVES: 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.

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

Conditions
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Leukemia, Lymphocytic, Chronic

Intervention / Treatment
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* Biological: CLL vaccine using DNA plasmid vector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Binet Stage A Chronic Lymphocytic Leukemia (CLL) WHO performance status of 2 or less. A life expectancy of at least one year. Greater than 18 years of age. Availability of CLL cells which can be used for DNA extraction and processing. A platelet count greater than 100 x 109/l. Ability to provide full informed consent. Exclusion Criteria: Previous chemotherapy or radiotherapy. Presence of a monoclonal band on serum electrophoresis. Presence of clinically significant levels of anti-DNA antibodies, anti-muscle antibodies or rheumatoid factors or who have active autoimmune disease. Presence of antibodies to human immunodeficiency virus (HIV) and known carriers of hepatitis B or hepatitis C virus. Presence of other serious medical condition e.g. congestive heart failure. Presence of other malignancies. Pregnancy, lactation, or not using contraceptive measures. Concurrent use of other anti-cancer therapy. Patients allergic to tetanus vaccine.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine<br> | Biological: CLL vaccine using DNA plasmid vector<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) |  | Continuous reassessment up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA, CLL, Chronic Lymphocytic Leukemia, Binet Stage A, Vaccination, Idiotypic, Genetic, Deoxyribonucleic acid