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

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ClinicalTrials.gov Identifier: NCT00038415
Recruitment Status : Terminated (Vaccine unavailable.)
First Posted : May 31, 2002
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic Biological: CLL vaccine using DNA plasmid vector Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Study Start Date : December 2001
Actual Primary Completion Date : July 2004
Actual Study Completion Date : January 2005


Arm Intervention/treatment
Experimental: Vaccine Biological: CLL vaccine using DNA plasmid vector



Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Continuous reassessment up to 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038415


Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael J. Keating, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038415     History of Changes
Other Study ID Numbers: DM99-412
First Posted: May 31, 2002    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Binet Stage A
Vaccination
Idiotypic
Genetic
Deoxyribonucleic acid
DNA

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Vaccines
Immunologic Factors
Physiological Effects of Drugs