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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphocytic, Chronic

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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 CenterHouston, Texas  77030-4096