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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00442130 |
Purpose
The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patients's own cancer cells, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.
| Condition | Intervention | Phase |
|
Chronic Lymphocytic Leukemia |
Biological: GM-K562 vaccine Procedure: stem cell transplantation |
Phase I |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| ChemIDplus related topics: | Tacrolimus Sargramostim Granulocyte-macrophage colony-stimulating factor Tacrolimus anhydrous |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
| Official Title: | Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination With Lethally Irradiated Autologous Tumor Cells Admixed With Granulocyte Macrophage-Colony Stimulating Factor Secreting K562 Cells |
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | February 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Catherine J. Wu, MD | 617-632-5943 | cwu@partners.org |
| Contact: Laura Spring | lspring@partners.org |
| United States, Massachusetts | |||||
| Dana-Farber Cancer Institute | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Dana-Farber Cancer Institute |
| Brigham and Women's Hospital |
| Principal Investigator: | Catherine J. Wu, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute ( Catherine Wu, MD ) |
| Study ID Numbers: | 06-196 |
| First Received: | February 27, 2007 |
| Last Updated: | December 20, 2007 |
| ClinicalTrials.gov Identifier: | NCT00442130 |
| Health Authority: | United States: Food and Drug Administration |
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