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

Johns Hopkins Medicine

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Lymphoma

Treatments: Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00478062

P50CA096888 (U.S. NIH Grant/Contract)

JHOC-NA_00007920

JHOC-J06143

P30CA006973 (U.S. NIH Grant/Contract)

J06143 CDR0000544408

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

Cell vaccine after initial therapy for Hodgkin lymphoma

Experimental group

Description:

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

Treatment:

Procedure: adjuvant therapy

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