Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224354
Status:
WITHDRAWN
Last Update Posted:
2012-05-21
First Post:
2005-09-21
Brief Title:
Lymphocytic B-Leukemia B-CLL wHuman IL-2 Gene Modified Human CD40 Ligand-Expressing Autologous Tumor Cells
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Treatment of Chronic Lymphocytic B-Leukemia B-CLL With Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells After Depletion of Regulatory T Cells
Status:
WITHDRAWN
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLONTAK
Brief Summary:
In the laboratory we will put a special gene into cancer cells that have been taken from the subject This gene will make the cells produce interleukin 2 IL-2 which may help the patients immune system kill cancer cells Also we will use CD40 ligand CD40L with the IL-2 Studies of cancers in animals and in cancer cells that are grown in laboratories have suggested adding the CD40L helps the IL-2 work better Some of these new cells will then be given back to the subject as a vaccine shot
We believe that a part of the subjects immune system cells called T-reg cells might try to kill off these special cells If the T-reg cells do that the vaccine would not work as well or last as long To try to avoid this before the special cells are put back into the subjects body we will give them an intravenous IV dose of IL-2 immunotoxin called denileuk diftitox or ONTAK ONTAK should get rid of some of the T-reg cells in the subjects body which should help the special cells work better and longer
The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2 with the vaccine
We believe that a part of the subjects immune system cells called T-reg cells might try to kill off these special cells If the T-reg cells do that the vaccine would not work as well or last as long To try to avoid this before the special cells are put back into the subjects body we will give them an intravenous IV dose of IL-2 immunotoxin called denileuk diftitox or ONTAK ONTAK should get rid of some of the T-reg cells in the subjects body which should help the special cells work better and longer
The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2 with the vaccine
Detailed Description:
This is a phase I trial to assess the safety of depleting regulatory T Treg cells using 1-3 doses of an interleukin-2 immunotoxin directed to the CD25 antigen denileukin diftitox ONTAK in chronic lymphocytic leukemia B-CLL patients followed by six subcutaneous SC injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 hIL-2 and to express human CD40 ligand hCD40L Patients will receive a fixed dose 2 x 10e7 of IL-2 secreting B-cells together with 2 x 10e7 hCD40L expressing B-cells representing a safe well tolerated and immunogenic dose in our previous dose escalation study
All eligible patients will be treated with six injections Any patient whose disease regresses after the administration of 6 injections may be offered further injections of tumor vaccine if sufficient vaccine is available There will be no use of placebo or control subjects
All eligible patients will be treated with six injections Any patient whose disease regresses after the administration of 6 injections may be offered further injections of tumor vaccine if sufficient vaccine is available There will be no use of placebo or control subjects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CLONTAK | None | None | None |