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| Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00694330 |
Purpose
This research study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. This newly developed vaccine may stop cancer cells from growing.
| Condition | Intervention | Phase |
|
Glioma |
Biological: GM-K562 Vaccination |
Phase I |
| MedlinePlus related topics: | Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor |
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2011 (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: William Curry, MD | 617-726-3779 | |
| Contact: Azra Haider | 617-726-2821 | ahaider1@partners.org |
| United States, Massachusetts | |||||
| Massachusetts General Hospital | Recruiting | ||||
| Boston, Massachusetts, United States, 02114 | |||||
| Principal Investigator: William Curry, MD | |||||
| Dana-Farber Cancer Institute | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Principal Investigator: Patrick Wen, MD | |||||
| Massachusetts General Hospital |
| Dana-Farber Cancer Institute |
| Brigham and Women's Hospital |
| Principal Investigator: | William Curry, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Massachusetts General Hospital ( William Curry, MD ) |
| Study ID Numbers: | 06-349 |
| First Received: | June 6, 2008 |
| Last Updated: | June 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00694330 |
| Health Authority: | United States: Food and Drug Administration |
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