Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

DM99-412


NCT ID:

NCT00038415


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Vaccine unavailable.


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

2


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael J. Keating, MD
Principal Investigator
UT MD Anderson Cancer Center

Study Dates

Start Date:December 2001
Completion Date:January 2005
Completion Type:Actual
Primary Completion Date:July 2004
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 30, 2018
First Received Date:May 30, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Maximum Tolerated Dose (MTD)
Time Frame:Continuous reassessment up to 1 year
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:CLL vaccine using DNA plasmid vector
Arm Name:Vaccine

Study Arms

Study Arm Type:Experimental
Arm Name:Vaccine

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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