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

This study has been terminated.
(Poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00478062
First received: May 23, 2007
Last updated: January 25, 2012
Last verified: January 2012
  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 1
Phase 2

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:


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

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 October 01, 2014