Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
M.D. Anderson Cancer Center
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
