Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia

This study has been completed.

First Received: June 29, 2005 Last Updated: December 18, 2007 History of Changes

Sponsored by:	Cell Genesys
Information provided by:	Cell Genesys
ClinicalTrials.gov Identifier:	NCT00116467

Purpose

The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).

Condition	Intervention	Phase
Acute Myelogenous Leukemia	Biological: GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line

Further study details as provided by Cell Genesys:

Estimated Enrollment:	55
Study Start Date:	March 2001
Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.
No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.

Exclusion Criteria:

Prior myelodysplastic disorder, or treatment-related leukemia.
Prior myeloproliferative disease.
Acute promyelocytic leukemia (APL).
Prior chemotherapy for a malignant or nonmalignant disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116467

Locations

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Cell Genesys

More Information

No publications provided

Study ID Numbers:	K-0009, K-0009
Study First Received:	June 29, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00116467 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cell Genesys:

AML
Acute Myelogenous Leukemia
GVAX

Vaccine
Stem Cell Transplant
Autologous

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on May 07, 2009