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

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	35
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2010 (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 at Johns Hopkins ( Yvette Leslie Kasamon )
Study ID Numbers:	CDR0000544408, JHOC-J06143, JHOC-NA_00007920
Study First Received:	May 23, 2007
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00478062 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Adjuvants, Immunologic

Hodgkin's Disease
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on May 07, 2009