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NCT00004988 · ClinicalTrials.gov registry record · Phase 1
Treatment of Patients With Cancer With Genetically Modified Salmonella Typhimurium Bacteria
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT00004988: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00004988 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004988, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This study will examine the safety and toxicities of intravenously administering a genetically modified type of Salmonella bacteria (VNP20009) and its impact on tumor growth in advanced or metastatic cancer (cancer that has spread from the primary site). The first patients in the study will be given the smallest dose of VNP20009, and those who enter later will receive increasingly larger doses. This will be done to determine the maximum dose that can be given without serious side effects. Normally, Salmonella bacteria ingested in food or water can cause diarrhea or more severe illness. The bacteria in this study are altered genetically so they can be injected through a vein and circulate in the blood with less likelihood of causing side effects. It is believed that the bacteria will travel in the blood to the tumor and infect it. In studies of mice, tumor growth slowed in animals whose tumors were infected with VNP0009. Patients with advanced or metastatic cancer 18 years of age or older whose disease is not responding to standard treatment, or for which there is no treatment, may be eligible for this study. Candidates will undergo a medical history and physical examination, including blood tests, scans, X-rays, electrocardiogram, and urine, stool and blood cultures. Study participants will be admitted to the hospital for 2 to 4 days. On day 1, they will receive the first dose of VNP0009, infused over a 30-minute period through an intravenous catheter (a small plastic tube inserted into a vein). Blood will be drawn every day to determine if the bacteria are still in the body. After discharge, patients will return to the hospital on days after approximately 1-2 weeks and again after 4-5 weeks for additional blood tests to measure levels of the bacteria and for collection of blood, urine and stool samples. Patients whose tumors are on or just beneath the skin may be asked to have one or two tumors removed surgically. Patients will have tests after approximately 4-
Interventions
- DRUG VNP20009
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2000-03 |
| Est. Completion | 2002-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004988
The ClinicalTrials.gov registry entry for NCT00004988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 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 VNP20009 is the first listed.
NCT00004988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004988 about?
NCT00004988 is a clinical study titled "Treatment of Patients With Cancer With Genetically Modified Salmonella Typhimurium Bacteria". This study will examine the safety and toxicities of intravenously administering a genetically modified type of Salmonella bacteria (VNP20009) and its impact on tumor growth in advanced or metastatic cancer (cancer that has spread from the primary site). The first patients in the study will be given...
What is the current status of trial NCT00004988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2000-03. Estimated completion is 2002-10.
What interventions are being tested in trial NCT00004988?
The interventions under investigation include: VNP20009 (DRUG).
Who is sponsoring clinical trial NCT00004988?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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