Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478062
Status:
TERMINATED
Last Update Posted:
2018-02-28
First Post:
2007-05-23
Brief Title:
Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkins Lymphoma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
KGEL Vaccine After Initial Therapy of Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells
PURPOSE This phase III trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkins lymphoma
PURPOSE This phase III trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine immunologic responses in patients who have completed first-line therapy for Hodgkins lymphoma treated with Hodgkins antigens-GM-CSF-expressing cell vaccine
Determine the durability of these immunologic responses in these patients
Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular vaccine responses
Determine the safety and tolerability of this vaccine in these patients
OUTLINE Beginning 4-6 months after last chemotherapy patients receive Hodgkins antigens-GM-CSF-expressing cell vaccine on day 1 Treatment repeats every 3 weeks for up to 4 courses
Immunologic responses are serially monitored along with disease status
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Determine immunologic responses in patients who have completed first-line therapy for Hodgkins lymphoma treated with Hodgkins antigens-GM-CSF-expressing cell vaccine
Determine the durability of these immunologic responses in these patients
Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular vaccine responses
Determine the safety and tolerability of this vaccine in these patients
OUTLINE Beginning 4-6 months after last chemotherapy patients receive Hodgkins antigens-GM-CSF-expressing cell vaccine on day 1 Treatment repeats every 3 weeks for up to 4 courses
Immunologic responses are serially monitored along with disease status
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
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 |
|---|---|---|---|
| P50CA096888 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J06143 | None | None | None |
| JHOC-NA_00007920 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |