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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00478062
Recruitment Status : Terminated (Poor accrual)
First Posted : May 24, 2007
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma
Study Start Date : April 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cell vaccine after initial therapy for Hodgkin lymphoma
Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.
 Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine
Procedure: adjuvant therapy


Outcome Measures
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Primary Outcome Measures :
  1. Immunologic Response [ Time Frame: 9 months ]
  2. Durability of Immunologic Response [ Time Frame: 2 years ]
  3. Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses [ Time Frame: 2 years ]
  4. Safety and Tolerability [ Time Frame: After administration of last vaccine at 9 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478062


Locations
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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 at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: Yvette L. Kasamon, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00478062    
Other Study ID Numbers: J06143 CDR0000544408
P50CA096888 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J06143
JHOC-NA_00007920
First Posted: May 24, 2007    Key Record Dates
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018
Last Verified: October 2016
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases