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NCT00328861 · ClinicalTrials.gov registry record · Phase 2
Natural Killer Cells Plus IL-2 Following Chemotherapy to Treat Advanced Melanoma or Kidney Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT00328861: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00328861 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00328861, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Background: * Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are important in the immune response to cancer. * IL-2 (Aldesleukin) is a substance the body makes that controls the growth and function of many types of cells. The Food and Drug Administration has approved IL-3 for treating metastatic melanoma and kidney cancer. (Metastatic disease is cancer that has spread beyond the primary site.) Objectives: To determine the safety and effectiveness of treating metastatic melanoma and kidney cancer with laboratory-treated NK cells and IL-2. Eligibility: Patients 18 years of age or older with metastatic melanoma or kidney cancer who have previously been treated with high-dose IL-2. Design: * Leukapheresis. Patients under leukapheresis to obtain NK cells for the treatment regimen. Blood is collected through a needle in an arm vein and directed through a cell separator machine where white blood cells are extracted. The rest of the blood is returned to the patient through a needle in the other arm. NK cells are removed from the white blood cells and treated for re-infusion into the patient. * Chemotherapy. Starting 8 days before infusion of the treated NK cells, patients receive intravenous (IV, through a vein) infusions of cyclophosphamide and fludarabine to suppress the immune system. * NK cell infusion. Patients receive a 30-minute IV infusion of NK cells 2 days after the last dose of chemotherapy. * IL-2 therapy. Within 24 hours of the NK cell infusion, patients receive high-dose IL-2 as a 15-minute IV infusion every 8 hours for up to 5 days. A second cycle of IL-2 is given about 14 days after the first. * Blood tests and biopsy. Patients have frequent blood tests during the treatment period and may be asked to undergo a biopsy (surgical removal of a small piece of tumor or lymph node) at the end of treatment to look at the effects of the treatment on the tumor immune cells. * Follow-up evaluation. Patients are evaluated 4-6 week
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL IL-2
- DRUG Natural Killer (NK) Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00328861
The ClinicalTrials.gov registry entry for NCT00328861 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 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 4 interventions - of which Cyclophosphamide is the first listed.
NCT00328861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00328861 about?
NCT00328861 is a clinical study titled "Natural Killer Cells Plus IL-2 Following Chemotherapy to Treat Advanced Melanoma or Kidney Cancer". Background: * Natural killer (NK) cells are large lymphocytes (a type of white blood cell) that are important in the immune response to cancer. * IL-2 (Aldesleukin) is a substance the body makes that controls the growth and function of many types of cells. The Food and Drug Administration has appro...
What is the current status of trial NCT00328861?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2006-05. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00328861?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), IL-2 (BIOLOGICAL), Natural Killer (NK) Lymphocytes (DRUG).
Who is sponsoring clinical trial NCT00328861?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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