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

Tracking Information
First Received Date ^ICMJE	May 30, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	December 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

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 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 characterise 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 Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Leukemia, Lymphocytic, Chronic
Intervention ^ICMJE	Biological: CLL vaccine using DNA plasmid vector
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	25
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion: Patients with Binet Stage A 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: 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 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038415
Responsible Party
Study ID Numbers ^ICMJE	DM99-412
Study Sponsor ^ICMJE	M.D. Anderson Cancer Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	M.D. Anderson Cancer Center
Verification Date	January 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP