Back to resultsA Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Primary Purpose
Leukemia, Lymphocytic, Chronic
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CLL vaccine using DNA plasmid vector
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic focused on measuring Chronic Lymphocytic Leukemia, CLL, Binet Stage A, Vaccination, Idiotypic, Genetic, Deoxyribonucleic acid, DNA
Eligibility 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.
Sites / Locations
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccine
Arm Description
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD)
Secondary Outcome Measures
Full Information
NCT ID
NCT00038415
First Posted
May 30, 2002
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00038415
Brief Title
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Official Title
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Vaccine unavailable.
Study Start Date
December 2001 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
OBJECTIVES:
To determine if patients with Binet Stage A CLL generate an immune response to an antigen delivered by a DNA vaccine.
To determine if patients with Binet Stage A CLL generate an immune response to a tumor derived antigen delivered by a DNA vaccine.
To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses.
To characterize any adverse effects of idiotypic vaccination with a DNA vaccine.
To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s Stage A CLL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic
Keywords
Chronic Lymphocytic Leukemia, CLL, Binet Stage A, Vaccination, Idiotypic, Genetic, Deoxyribonucleic acid, DNA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CLL vaccine using DNA plasmid vector
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Time Frame
Continuous reassessment up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Keating, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website
Learn more about this trial
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
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