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

Phase 1

Terminated

• Conditions: Lymphoma
• Interventions: Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine; Procedure: adjuvant therapy

• Registration Number: NCT00478062
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Detailed 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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-24
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2016-10
• Results First Submitted: 2018-01-31
• Results First Submitted QC: 2018-01-31
• Last Update Submitted: 2018-01-31
• Results First Posted: 2018-02-28
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cell vaccine after initial therapy for Hodgkin lymphoma	adjuvant therapy	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.
Cell vaccine after initial therapy for Hodgkin lymphoma	Hodgkin's antigens-GM-CSF-expressing cell vaccine	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States