Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
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|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|
|Primary Completion Date :||June 2008|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|