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

Lymphoma Clinical Trial

Official title:

KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00478062
• Other study ID #: J06143 CDR0000544408
• Secondary ID: P50CA096888P30CA
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: May 23, 2007
• Last updated: January 31, 2018
• Start date: April 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2016
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

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

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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