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NCT00923741 · ClinicalTrials.gov registry record · Phase 1
Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00923741: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923741 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923741, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment. Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in body secretions such as breast milk, tears and saliva. In previous studies, talactoferrin improved life span in patients with NSCLC without causing toxic side effects. Objectives: To examine the effects of talactoferrin on the immune system and determine its effectiveness in treating NSCLC. Eligibility: Patients with advanced NSCLC who have tissue type HLA-A2 and whose cancer has gotten worse following at least one course of treatment. Design: Talactoferrin treatment: Patients take liquid talactoferrin twice a day for 12 weeks, followed by 2 weeks off the drug. Treatment may continue in these 14-week cycles depending on the drug side effects and the response of the tumor. Evaluations: Patients are evaluated at the clinic with a physical examination, check of vital signs and blood tests every 3 weeks. CT scans: Patients have CT scans to monitor disease before starting treatment, again at 6 weeks and 12 weeks and then every 12 weeks during the duration of treatment. Apheresis: Quantities of white blood cells called lymphocytes are collected through a procedure called apheresis in order to measure the immune response to treatment. In this procedure, blood is collected through a needle placed in a vein in the arm (similar to donating blood) and circulated through a cell separator machine. The lymphocytes are extracted and the rest of the blood is returned to the body through the same needle.
Interventions
- PROCEDURE Apheresis
- DRUG Talactoferrin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-06-19 |
| Est. Completion | 2010-02-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923741
The ClinicalTrials.gov registry entry for NCT00923741 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Apheresis is the first listed.
NCT00923741 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923741 about?
NCT00923741 is a clinical study titled "Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer". Background: More effective therapies are needed for patients with non-small cell lung cancer (NSCLC) whose disease has advanced or spread beyond the original site following standard treatment. Talactoferrin is a genetically engineered form of the human protein lactoferrin, found in body secretions...
What is the current status of trial NCT00923741?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2008-06-19. Estimated completion is 2010-02-01.
What interventions are being tested in trial NCT00923741?
The interventions under investigation include: Apheresis (PROCEDURE), Talactoferrin (DRUG).
Who is sponsoring clinical trial NCT00923741?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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