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

This study has been terminated.
(Poor accrual)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: May 23, 2007
Last updated: October 14, 2016
Last verified: October 2016

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.

Condition Intervention Phase
Lymphoma Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine Procedure: adjuvant therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Immunologic response
  • Durability of immunologic response
  • Utility of Epstein-Barr virus reporter system for monitoring cellular vaccine responses
  • Safety and tolerability

Enrollment: 1
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of classic Hodgkin's lymphoma
  • Must have completed first-line therapy without evidence of disease progression


  • HIV negative


  • See Disease Characteristics
  • No more than 6 months since prior chemotherapy or radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00478062

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00478062     History of Changes
Other Study ID Numbers: J06143 CDR0000544408
P50CA096888 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
Study First Received: May 23, 2007
Last Updated: October 14, 2016

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017