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| Sponsored by: |
Dana-Farber Cancer Institute |
|---|---|
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00487305 |
Purpose
The purpose of this study is to compare the safety and immune activity of three doses of tumor vaccine. In recent years, researchers at the Dana-Farber Cancer Institute have discovered that vaccines made from patient's own cancer cell, 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. GM-CSF is a naturally occuring hormone in the body that helps our immune system fight infections and diseases. One of the goals of this study is to determine whether these vaccinations will improve the immune system's ability to recognize and destroy the participant's lymphoma cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Follicular Lymphoma |
Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
| Official Title: | A Phase I Trial of Vaccination With Lethally Irradiated Lymphoma Cells Admixed With Granulocyte-Macrophage Colony Stimulating Factor Secreting K562 Cells for the Treatment of Previously Untreated or Relapses Follicular Lymphoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Group 3 will receive a larger dose than Group 2.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eric Jacobsen, MD | 617-632-6633 | edjacobsen@partners.org |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Eric Jacobsen, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute ( Eric Jacobsen, MD ) |
| Study ID Numbers: | 06-275 |
| Study First Received: | June 15, 2007 |
| Last Updated: | March 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00487305 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
GM-CSF vaccine K562 |
|
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Follicular Lymphoma, Non-Hodgkin |
Lymphoproliferative Disorders Follicular Lymphoma Lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |