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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-06-30

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.

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cell vaccine after initial therapy for Hodgkin lymphoma

Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.

Group Type EXPERIMENTAL

Hodgkin's antigens-GM-CSF-expressing cell vaccine

Intervention Type BIOLOGICAL

adjuvant therapy

Intervention Type PROCEDURE

Interventions

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Hodgkin's antigens-GM-CSF-expressing cell vaccine

Intervention Type BIOLOGICAL

adjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No