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

This study is currently recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
Official Title  KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma
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 Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
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 ]
Secondary Outcome Measure 
Condition  Lymphoma
Intervention  Drug: Hodgkin's antigens-GM-CSF-expressing cell vaccine
Procedure: adjuvant therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  35
Start Date  April 2007
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00478062
Organization ID CDR0000544408
Secondary IDs †† JHOC-J06143, JHOC-NA_00007920
Study Sponsor  Sidney Kimmel Comprehensive Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Yvette L. Kasamon, MD     Sidney Kimmel Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date June 2007
First Received Date  May 23, 2007
Last Updated Date May 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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