Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038415
Status:
TERMINATED
Last Update Posted:
2018-10-31
First Post:
2002-05-30
Brief Title:
A Phase III Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Vaccine unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is learn if a vaccine that contains the patients 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 patients immune response or whether the patients body recognizes the DNA vaccine In addition side effects and reactions to the vaccine will be evaluated
Detailed Description:
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 characterize any adverse effects of idiotypic vaccination with a DNA vaccine
5 To determine if DNA idiotypic vaccination is capable of inducing remission in Binets Stage A CLL
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 characterize any adverse effects of idiotypic vaccination with a DNA vaccine
5 To determine if DNA idiotypic vaccination is capable of inducing remission in Binets Stage A CLL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None