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A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2001
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 30, 2002
CompletedFirst Posted
Study publicly available on registry
May 31, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedOctober 31, 2018
October 1, 2018
2.6 years
May 30, 2002
October 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD)
Continuous reassessment up to 1 year
Study Arms (1)
Vaccine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J. Keating, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2002
First Posted
May 31, 2002
Study Start
December 1, 2001
Primary Completion
July 1, 2004
Study Completion
January 1, 2005
Last Updated
October 31, 2018
Record last verified: 2018-10