Safety Study Looking at the Use of a Natural Killer Cell Line Against Hematological Malignancies
The purpose of this study is to find out how many irradiated natural killer (NK) cells can be safely given to patients with cancer that has recurred after an autologous stem cell transplant, and to see what effects (good and bad) it has on the patient and their cancer. This research is being done because currently, there is no cure or effective treatment for blood-borne cancers when it has come back after an autologous stem cell transplant.
Biological: NK-92 cells
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose Escalation Study of NK-92 Cell Infusions in Patients With Hematological Malignancies in Relapse After Autologous Stem Cell Transplantation.|
- Determine if there are any dose limiting toxicities to this therapy, as well as the maximum tolerated dose. [ Time Frame: Day 1, 3, and 5 of each cycle ] [ Designated as safety issue: Yes ]
- Document any preliminary efficacy information from the NK-92 cell infusion. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Assess any immune response directed against the infused NK-92 cells. [ Time Frame: 28 days after each cycle ] [ Designated as safety issue: Yes ]
- Determine kinetics of infused NK92 cells. [ Time Frame: Pre-infusion, 15 min, 2h, 6h, 24h, 48h, 168h post infusion ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: NK-92 cells
Preparation of irradiated NK-92 cells suspended in a saline and plasma solution. NK-92 working cell bank was established from a master cell bank supplied by Conkwest Inc. (San Diego CA).
Biological: NK-92 cells
Cells are administered as an intravenous infusion over one hour on days 1, 3 and 5 of each cycle of treatment. Patients can receive up to 6 cycles, which are administered monthly. Cell dosage is as follows:
Patients with hematological malignancies such as acute leukemia, lymphoma, Hodgkin's disease and myeloma, are generally treated initially with chemotherapy, radiotherapy or a combination of both. High dose therapy and autotransplantation are often utilized in the management of such patients, either as part of initial therapy or for treatment of relapsed disease. When a patient's cancer relapses after transplantation, the prognosis is dismal. Therapeutic options are usually limited to palliative chemotherapy and/or local radiation, and for persons with excellent performance status experimental treatments are considered on an ad hoc basis.
Much interest in the last decade has focused on the role of cellular and immunotherapy in this setting. Cancer vaccines and the administration of adoptive cellular and immunotherapy have the theoretical advantage of being non cross-reactive with previous treatments (such as radiotherapy and chemotherapy) and are currently under investigation using a variety of methodologies. NK cells comprise roughly 15% of all lymphocytes in the peripheral blood. They normally function as part of the innate immune system, which provides the body's initial response to infection and malignancy. However, patients with malignancies frequently have impaired NK cell function, as evidenced by reduced in vitro proliferative responses and reduced cytotoxic activity. The infusion of an irradiated NK cell line is appealing as it is a source of cells that can be expanded to therapeutic quantities, and retains anti-tumor activity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990717
|Contact: Jan McCrae, RN||416-946-4500 ext firstname.lastname@example.org|
|Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: Armand Keating, MD|
|Sub-Investigator: Michael Crump, MD|
|Sub-Investigator: Vikas Gupta, MD|
|Principal Investigator:||Armand Keating, MD||Princess Margaret Hospital, Canada|