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| Descriptive Information Fields | |||||
| Brief Title † | Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma | ||||
| Official Title † | KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma | ||||
| 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 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Lymphoma | ||||
| Intervention † | Drug: Hodgkin's antigens-GM-CSF-expressing cell vaccine Procedure: adjuvant therapy |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 35 | ||||
| Start Date † | April 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00478062 | ||||
| Organization ID | CDR0000544408 | ||||
| Secondary IDs †† | JHOC-J06143, JHOC-NA_00007920 | ||||
| Study Sponsor † | Sidney Kimmel Comprehensive Cancer Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2007 | ||||
| First Received Date † | May 23, 2007 | ||||
| Last Updated Date | May 23, 2008 | ||||