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

Tracking Information
First Submitted Date ICMJE	May 30, 2002
First Posted Date ICMJE	May 31, 2002
Last Update Posted Date	August 2, 2012
Study Start Date ICMJE	December 2001
Actual Primary Completion Date	July 2004 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 25, 2011)	Maximum Tolerated Dose (MTD) [ Time Frame: Continuous reassessment up to 1 year ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00038415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Official Title ICMJE	A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Leukemia, Lymphocytic, Chronic
Intervention ICMJE	Biological: CLL vaccine using DNA plasmid vector
Study Arms	Experimental: Vaccine; Intervention: Biological: CLL vaccine using DNA plasmid vector
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: March 25, 2011)	2
Original Enrollment ICMJE; (submitted: June 23, 2005)	25
Actual Study Completion Date	January 2005
Actual Primary Completion Date	July 2004 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00038415
Other Study ID Numbers ICMJE	DM99-412
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	M.D. Anderson Cancer Center
Study Sponsor ICMJE	M.D. Anderson Cancer Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Michael J. Keating, MD UT MD Anderson Cancer Center
PRS Account	M.D. Anderson Cancer Center
Verification Date	August 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP