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| Sponsors and Collaborators: |
Tufts Medical Center University of Minnesota |
| Information provided by: | Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT00660166 |
Purpose
The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.
| Condition | Intervention | Phase |
|
Lymphoma Myeloma Leukemia |
Biological: NK-Cell Infusion |
Phase I |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
| ChemIDplus related topics: | Sodium chloride Diphenhydramine Diphenhydramine citrate Diphenhydramine hydrochloride Promethazine Promethazine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
| Official Title: | HLA Class I Haplotype Mismatched Natural Killer Cell Infusions After Autologous Stem Cell Transplant for Hematological Malignancies |
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Biological: NK-Cell Infusion
The infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight.
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Natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. It has been shown that NK cells coming from a "mismatched" person (a relative) have a better chance than the patient's own NK cells to recognize and kill cancer cells. These cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. A person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. This study uses NK cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells.
Eligibility
| Ages Eligible for Study: | 13 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have undergone an autologous stem cell transplant for the following diseases:
Exclusion Criteria:
Contacts and Locations| Contact: Hans Klingemann, MD, PhD | (617) 636-2520 ext 6-2520 | hklingemann@tuftsmedicalcenter.org |
| Contact: Carrie Grodman, RN | (617) 636.2682 ext 6-2682 | cgrodman@tuftsmedicalcenter.org |
| United States, Massachusetts | |||||
| Tufts Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02111 | |||||
| Contact: Hans Klingemann, MD, PhD 617-636-2520 ext 6-2520 hklingemann@tuftsmedicalcenter.org | |||||
| Contact: Carrie Grodman, RN (617) 636-2682 ext 6-2682 cgrodman@tuftsmedicalcenter.org | |||||
| Sub-Investigator: Andreas Klein, MD | |||||
| Sub-Investigator: Kellie Sprague, MD | |||||
| Sub-Investigator: David McKenna, MD | |||||
| Sub-Investigator: Howard Grodman, MD | |||||
| Sub-Investigator: Lawrence Wolfe, MD | |||||
| Sub-Investigator: Richard A. Van Etten, MD, PhD | |||||
| Sub-Investigator: Kenneth B. Miller, MD | |||||
| Tufts Medical Center |
| University of Minnesota |
| Principal Investigator: | Hans Klingemann, MD, PhD | Tufts Medical Center |
More Information
Cancer Center at Tufts Medical Center 
  |
| Responsible Party: | Tufts Medical Center ( Hans Klingemann, MD, PhD ) |
| Study ID Numbers: | Allogeneic NKCell post ABMT |
| First Received: | April 11, 2008 |
| Last Updated: | April 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00660166 |
| Health Authority: | United States: Food and Drug Administration |
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