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NCT00720785 · ClinicalTrials.gov registry record · Phase 1
Natural Killer Cells and Bortezomib to Treat Cancer
A Phase 1 study of Multiple Myeloma and Carcinoma, Non-Small Cell Lung, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT00720785 is a Phase 1 study of Multiple Myeloma and Carcinoma, Non-Small Cell Lung that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 35 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00720785, a Phase 1 study of Multiple Myeloma and Carcinoma, Non-Small Cell Lung, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
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,
Conditions Studied
Interventions
- DRUG Bortezomib
- BIOLOGICAL NK cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-08-01 |
| Est. Completion | 2021-04-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00720785
The ClinicalTrials.gov registry entry for NCT00720785 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Bortezomib is the first listed.
NCT00720785 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00720785 about?
NCT00720785 is a clinical study titled "Natural Killer Cells and Bortezomib to Treat Cancer". 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 wit...
What is the current status of trial NCT00720785?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2008-08-01. Estimated completion is 2021-04-06.
What conditions does trial NCT00720785 study?
This clinical trial studies the following conditions: Multiple Myeloma, Carcinoma, Non-Small Cell Lung, Chronic Myeloid Leukemia (CML), Pancreatic Ca, Colon/Rectal Ca.
What interventions are being tested in trial NCT00720785?
The interventions under investigation include: Bortezomib (DRUG), NK cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00720785?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00720785 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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