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NCT01160445 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Aldesleukin (IL-2) Following the Administration of Zanolimumab (Anti-CD4mAb) in Metastatic Melanoma and Metastatic Renal Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01160445: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01160445 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01160445, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: * Aldesleukin (IL-2) is a drug that can help to shrink tumors in some patients with metastatic renal cancer and metastatic melanoma. It is possible that removing certain white blood cells (known as CD4 cells) before IL-2 treatment may improve the treatment effects. * Zanolimumab is an antibody that works by destroying CD4 cells in the blood. Researchers are interested in determining whether zanolimumab can improve the results of IL-2 treatment if it is given before, during, and after IL-2 treatment. In addition, further research with zanolimumab may provide more information on how IL-2 treatment causes tumors to stop growing or shrink. Objectives: \- To evaluate the effectiveness of IL-2 treatment in conjunction with zanolimumab in individuals with metastatic cancer. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma or metastatic kidney cancer. Design: * Eligible participants will be screened with a full physical examination and medical history, imaging studies, and blood samples, including leukapheresis, to remove a sample of white blood cells for testing purposes. Participants may also have a colonoscopy and biopsies if they have received previous treatments that have been known to cause colon damage. * Participants will be treated with zanolimumab and IL-2 treatment for 9 weeks. * Zanolimumab will be given on an outpatient basis during weeks 1 through 4, 6, 8, and 9. In weeks 5 and 7, participants will receive zanolimumab as an inpatient in addition to IL-2 therapy. * Inpatient IL-2 treatment will be given during weeks 5 and 7. Up to 15 doses of IL-2 treatment will be given over a maximum of 5 days, followed by inpatient recovery time. * During week 5, participants will have tumor imaging studies prior to receiving zanolimumab and IL-2 treatment. * About 2 weeks after the treatment period, participants will return to the clinical center for a 2-day evaluation with a physical examination, imagi
Interventions
- DRUG Aldesleukin
- DRUG Zanolimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01160445
The ClinicalTrials.gov registry entry for NCT01160445 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 9 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 Aldesleukin is the first listed.
NCT01160445 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01160445 about?
NCT01160445 is a clinical study titled "Phase II Study of Aldesleukin (IL-2) Following the Administration of Zanolimumab (Anti-CD4mAb) in Metastatic Melanoma and Metastatic Renal Cancer". Background: * Aldesleukin (IL-2) is a drug that can help to shrink tumors in some patients with metastatic renal cancer and metastatic melanoma. It is possible that removing certain white blood cells (known as CD4 cells) before IL-2 treatment may improve the treatment effects. * Zanolimumab is an a...
What is the current status of trial NCT01160445?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2010-06. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01160445?
The interventions under investigation include: Aldesleukin (DRUG), Zanolimumab (DRUG).
Who is sponsoring clinical trial NCT01160445?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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