Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of classic Hodgkin's lymphoma Must have completed first-line therapy without evidence of disease progression PATIENT CHARACTERISTICS: HIV negative PRIOR CONCURRENT THERAPY: See Disease Characteristics No more than 6 months since prior chemotherapy or radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell vaccine after initial therapy for Hodgkin lymphoma<br>Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. | Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine<br> <br> Procedure: adjuvant therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunologic Response |  | 9 months | 
| Durability of Immunologic Response |  | 2 years | 
| Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses |  | 2 years | 
| Safety and Tolerability |  | After administration of last vaccine at 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma