Natural Killer Cells and Bortezomib to Treat Cancer

Completed · Phase 1

Conditions studied: Chronic Myeloid Leukemia (CML), Pancreatic Ca, Colon/Rectal Ca, Multiple Myeloma, Carcinoma, Non-Small -Cell Lung

In brief

Natural killer (NK) cells are white blood cells that have a limited ability to kill cancer cells. This ability might be enhanced if they are given 24 hours after an injection of the drug bortezomib. This study will determine the following: * What dose of NK cells can be given safely to subjects with metastatic solid tumors or leukemia. * The effectiveness and side effects of NK cell therapy * How the body handles NK cells. People between 18 and 70 years of age who have a solid tumor or leukemia, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures: Apheresis to collect NK cells. For this procedure, a catheter (plastic tube) is placed in a vein in the subject s arm. Blood flows from the vein into a cell separator machine, which separates the white cells from the other blood components. The white cells are extracted and the rest of the blood is returned to the body through a second tube placed in a vein in the other arm. Chemotherapy with the drug pentostatin to suppress the immune system and prevent it from attacking the NK cells that will be infused. Chemotherapy with bortezomib to increase NK cell function. Infusion of the NK cells. In this dose-escalating study, successive groups of patients entering the study receive increasingly higher numbers of cells to determine the highest safe dose level. Up to ten dose levels may be studied. Interleukin-2 drug therapy to maintain NK cell activity. Evaluations during therapy including: * Clinical assessment, history and review of medications * Blood draws for routine and research tests. * Pharmacokinetics study after the NK infusion to see how the body handles the cells. For this test, the number of NK cells in the blood are measured over time. This requires drawing about 1 teaspoon of blood at 15 minutes, 30 minutes, 1, 2, 4, 8, 12, and 24 hours after the infusion (day 1); then every 24 hours on days 2 through 7, then once on days 10, 14, and 21. * Bone marrow biopsy (subjects with leukemia only). * Chest x-ray. * CT scan, bone scan and PET scan, if indicated, for disease evaluation. Subjects who respond well after one treatment cycle may be eligible to continue NK cell therapy. ...

Key facts

Study ID

NCT00720785

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

35

Starts

2008-08-01

Expected to finish

2021-04-06

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Disease not evaluable radiographically (applies to solid tumor patients only).
• Disease involving greater than 25% of the liver radiographically (estimated based on review of liver lesions seen on CT scan).
• History of an allogeneic hematopoietic stem cell transplant.
• Brain metastases (with the exception of patients with a single brain metastasis less than 1cm treated with either sterotactic or gamma knife radiotherapy) due to poor prognosis and potential for neurological dysfunction that would confound evaluation of neurological and other adverse events).
• Peripheral neuropathy of grade greater than 1, which would require reduction of bortezomib dose.
• Acute diffuse infiltrative pulmonary disease.
• Acute pericardial disease.
• Life expectancy less than 3 months.
• ECOG performance status 2, 3 or 4.
• Uncontrolled concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia. Patients with symptoms of coronary artery disease, cardiac arrhythmias or an abnormal thallium stress test must be evaluated and cleared by cardiology prior to enrollment.
• Ongoing or active infection
• Contraindication for administration of pentostatin, bortezomib, and/or interleukin-2.
• Allergy or hypersensitivity to bortezomib, boron or mannitol by history.
• Concurrent use of corticosteroids.
• For all tumor types:
• Marrow function characterized by
• Absolute neutrophil count less than 500/mcL (must be present off growth factors)
• Organ function characterized by
• Total bilirubin greater than 3 times upper limit of normal
• AST (SGOT)/ALT (SGPT) greater than 4 times upper limit of normal
• Creatinine clearance less than 50 cc/min based on a 24 hour urine collection
• Left ventricular ejection fraction less than 40% by echocardiogram (ECHO)
• Hypercalcemia greater than 2.5 mmol/L
• For all Hematologic malignancies:
• Marrow function characterized by

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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