Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkin's lymphoma.
Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma|
- Immunologic response [ Designated as safety issue: No ]
- Durability of immunologic response [ Designated as safety issue: No ]
- Utility of Epstein-Barr virus reporter system for monitoring cellular vaccine responses [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
- Determine immunologic responses in patients who have completed first-line therapy for Hodgkin's lymphoma treated with Hodgkin's 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 Hodgkin's 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478062
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Yvette L. Kasamon, MD||Sidney Kimmel Comprehensive Cancer Center|