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A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach Clinical research trials and A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach. A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach  A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
For Condition: Leukemia, Lymphocytic, Chronic
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details: 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 characterise 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 25
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Additional Information:
Study ID Numbers: DM99-412;
Study Start Date: December 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038415
Other Leukemia, Lymphocytic, Chronic Studies:
1. A Pilot Study of Pivanex in Patients with Chronic Lymphocytic Leukemia
2. Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
3. A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)
4. Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
5. Chemotherapy Related Anemia
Related Studies:
Other Leukemia, Lymphocytic, Chronic Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
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