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NCT00091611 · ClinicalTrials.gov registry record · Phase 1
Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00091611: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00091611 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00091611, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * Some patients with advanced kidney cancer have immune cells that can recognize and kill their cancer, but the cells are not active enough or numerous enough to accomplish this on their own. * In recent studies of patients with advanced melanoma, some patients given special tumor-fighting cells (cells taken from the patient's tumor cells and grown in the laboratory) showed some anti-tumor response. Objectives: -To determine whether special tumor-fighting cells taken from the patient's blood or tumor and grown in the laboratory can cause tumors in patients with kidney cancer to shrink when they are given back to the patient along with interleukin-2. Eligibility: Patients 18 years of age or older with advanced kidney cancer. Design: * Up to 29 patients will be treated in this study. * Patients undergo tumor biopsy to collect tumor cells for creating special tumor-fighting cells for later infusion. * Patients undergo apheresis to collect stem cells for later re-infusion. For apheresis, whole blood is collected through a needle in an arm vein and circulated through a cell-separating machine where the stem cells are extracted. The rest of the blood is returned through the same needle or a needle in the other arm. * Before receiving the treated white cells, patients are given two drugs to suppress the immune system so the treated cells can work without interference from immune system cells. They are given cyclophosphamide over 2 days through a catheter (plastic tube inserted into a vein in the arm or neck) and fludarabine through the catheter over 15-30 minutes for the next 5 days. * The day after the last dose of fludarabine, the tumor-fighting cells are infused through a vein over 10-20 minutes. * Following the cell infusion, patients start treatment with high-dose interleukin-2 every 8 hours for a maximum of 12 doses. * Patients are evaluated with x-ray studies about 1 month after receiving the cells and interleukin 2 (IL-2) to look for tumor respons
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Mesna
- DRUG OKT3
- DRUG IL-2 (interleukin-2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2004-09 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00091611
The ClinicalTrials.gov registry entry for NCT00091611 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 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 5 interventions - of which Cyclophosphamide is the first listed.
NCT00091611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00091611 about?
NCT00091611 is a clinical study titled "Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer". Background: * Some patients with advanced kidney cancer have immune cells that can recognize and kill their cancer, but the cells are not active enough or numerous enough to accomplish this on their own. * In recent studies of patients with advanced melanoma, some patients given special tumor-fight...
What is the current status of trial NCT00091611?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2004-09. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00091611?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Mesna (DRUG), OKT3 (DRUG), IL-2 (interleukin-2) (DRUG).
Who is sponsoring clinical trial NCT00091611?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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