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NCT00059605 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00059605: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00059605 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00059605, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study the side effects of this experimental gene transfer at different doses, and will conduct tests to see if there are any effects on tumor size at different doses. Experimental transfer of the fus1 gene into humans has never been tried before. Objectives: * Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1) administered intravenously. * To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1 administered intravenously. * Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor and normal bronchial epithelial cell biopsies. * Assess any anti-cancer activity for DOTAP:Chol-fus1.
Interventions
- GENETIC DOTAP:Chol-fus1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2003-03 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059605
The ClinicalTrials.gov registry entry for NCT00059605 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DOTAP:Chol-fus1 is the first listed.
NCT00059605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059605 about?
NCT00059605 is a clinical study titled "Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer". The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the ...
What is the current status of trial NCT00059605?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2003-03. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00059605?
The interventions under investigation include: DOTAP:Chol-fus1 (GENETIC).
Who is sponsoring clinical trial NCT00059605?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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