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Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00478062   Information provided by National Cancer Institute (NCI)
First Received: May 23, 2007   Last Updated: March 31, 2009   History of Changes

May 23, 2007
March 31, 2009
April 2007
April 2010   (final data collection date for primary outcome measure)
  • Immunologic response [ Designated as safety issue: No ]
  • Durability of immunologic response [ Designated as safety issue: No ]
  • Utility of Epstein-Barr virus reporter system for monitoring cellular vaccine responses [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Immunologic response
  • Durability of immunologic response
  • Utility of Epstein-Barr virus reporter system for monitoring cellular vaccine responses
  • Safety and tolerability
Complete list of historical versions of study NCT00478062 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma

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.

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.

Phase I, Phase II
Interventional
Treatment, Open Label
Lymphoma
  • Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine
  • Procedure: adjuvant therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
35
 
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00478062
Yvette Leslie Kasamon, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
CDR0000544408, JHOC-J06143, JHOC-NA_00007920
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP