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Natural Killer Cells and Bortezomib to Treat Cancer

NCT00720785 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-07

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Bortezomib

Parenteral formulation. It is supplied as a 3.5 mg single use vial containing a sterile lyophilized powder that requires reconstitution.

BIOLOGICAL

NK cells

NK Cell Infusion

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Richard W Childs, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-01
Primary Completion
2021-04-06
Completion
2021-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00720785 on ClinicalTrials.gov