A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
18 Years
N/A
Both
Leukemia, Lymphocytic, Chronic
Trial Information
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD)
Outcome Time Frame:
Continuous reassessment up to 1 year
Safety Issue:
Yes
Principal Investigator
Michael J. Keating, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
DM99-412
NCT ID:
NCT00038415
Start Date:
December 2001
Completion Date:
January 2005
Related Keywords:
- Leukemia, Lymphocytic, Chronic
- Chronic Lymphocytic Leukemia
- CLL
- Binet Stage A
- Vaccination
- Idiotypic
- Genetic
- Deoxyribonucleic acid
- DNA
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
