Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00478062|
Recruitment Status : Terminated (Poor accrual)
First Posted : May 24, 2007
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine Procedure: adjuvant therapy||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Experimental: Cell vaccine after initial therapy for Hodgkin lymphoma
Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.
|Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine Procedure: adjuvant therapy|
- Immunologic Response [ Time Frame: 9 months ]
- Durability of Immunologic Response [ Time Frame: 2 years ]
- Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses [ Time Frame: 2 years ]
- Safety and Tolerability [ Time Frame: After administration of last vaccine at 9 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 at Johns Hopkins|