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

This study has been terminated.
(Vaccine unavailable.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038415
First received: May 30, 2002
Last updated: August 1, 2012
Last verified: August 2012

May 30, 2002
August 1, 2012
December 2001
July 2004   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) [ Time Frame: Continuous reassessment up to 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00038415 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Lymphocytic, Chronic
Biological: CLL vaccine using DNA plasmid vector
Experimental: Vaccine
Intervention: Biological: CLL vaccine using DNA plasmid vector
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
January 2005
July 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038415
DM99-412
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Michael J. Keating, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP