Clinical trial NCT00038415: A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Official title: A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Leukemia, Lymphocytic, Chronic
Keywords: Chronic Lymphocytic Leukemia
CLL
Binet Stage A
Vaccination
Idiotypic
Genetic
Deoxyribonucleic acid
DNA
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2002-05-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Continuous reassessment up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Michael J. Keating, MD
role: PRINCIPAL_INVESTIGATOR
References: