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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 isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach conditions. Clinical Trials Search.org is a site dedicated 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 occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 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 obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid 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. Participants typically obtain the most effective healthcare available for their A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid 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. Study of ONTAK in patients with B-Cell Chronic Lymphocytic Leukemia (CLL)
2. A Study of Motexafin Gadolinium for the Treatment of Chronic Lymphocytic Leukemia (CLL)
3. A Pilot Study of Pivanex in Patients with Chronic Lymphocytic Leukemia
4. Chemotherapy Related Anemia in Patients with Non-Myeloid Malignancies
5. Clofarabine in Chronic Lymphocytic Leukemia
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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