At a glance
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Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30)
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Cyclophosphamide, and 5 other interventions for Ovarian Cancer and 3 related conditions. Completed, enrolled 13 participants across 1 site.
Detailed Summary
This is a single center phase II trial designed to optimize a clinical platform of lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian, fallopian tube, primary peritoneal cancer and advanced metastatic breast cancer.
Study Details
Timeline
Interventions
Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).
Administered intravenously, 60 mg/kg, days -5 and -4.
Administered intravenously, CsA 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
Administered by infusion over less than 1 hour, no more than 8.0 x 10\^7 cells/kg will be given.
Will be given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 5 million units/m\^2 3 times per week for 6 doses).
Administered intravenously (IV) 10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9
Administered intravenously (IV) 1 mg/kg Days -2 to +9
Will be given subcutaneously at million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 3 million units/m\^2 3 times per week for 6 doses).