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NCT00055237 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00055237: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00055237 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00055237, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth. Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that is produced by the body and is involved in blood vessel growth. Bevacizumab may block the action of VEGF, and thus help shrink KS lesions. Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and is not life threatening may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, and, if needed, imaging studies to evaluate internal tumors. Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at a slower infusion rate. Patients will be evaluated with the following tests and procedures: * Physical examination, assessment of drug side effects, measurement of KS lesions, and photographs of lesions once a week for the first 6 weeks of therapy, and then every 3 weeks. * cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV) viral load in HIV-positive patients every 12 weeks. * Biopsies of lesions: upon entering the study, at week 12, and at the time of a response of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or later. * Additional biopsies, if requested. (Additional biopsies are not required.) * Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI) scans, if medically
Interventions
- BIOLOGICAL Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2003-02-26 |
| Est. Completion | 2010-03-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00055237
The ClinicalTrials.gov registry entry for NCT00055237 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 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 1 intervention - of which Bevacizumab is the first listed.
NCT00055237 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00055237 about?
NCT00055237 is a clinical study titled "Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients". This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth. Bevacizumab is an antibody to...
What is the current status of trial NCT00055237?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2003-02-26. Estimated completion is 2010-03-15.
What interventions are being tested in trial NCT00055237?
The interventions under investigation include: Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00055237?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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