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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 )

First Received on May 23, 2007.   Last Updated on January 25, 2012   History of Changes
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00478062
  Purpose

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 I
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma
U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478062

Locations
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)
Investigators
Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00478062     History of Changes
Other Study ID Numbers: J06143 CDR0000544408, P50CA096888, P30CA006973, JHOC-J06143, JHOC-NA_00007920
Study First Received: May 23, 2007
Last Updated: January 25, 2012
Health Authority: United States: Federal Government;   United States: Institutional Review Board;   United States: Food and Drug Administration

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
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012



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