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NCT00051480 · ClinicalTrials.gov registry record · Phase 2
Study of TNFerade™ Gene Therapy, Radiation, 5-FU and Cisplatin in Esophageal Cancer
A Phase 2 study, sponsored by GenVec.
- Completed
- Registry status
- Phase 2
- Development phase
NCT00051480 is a Phase 2 study that has completed, run by GenVec.
The verdict
NCT00051480, a Phase 2 study, has completed, sponsored by GenVec.
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study Summary
The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™ with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4 deleted) adenovirus vector containing the gene for TNF-alpha controlled by a radiation inducible promoter. This allows the expression of TNF-alpha to be greatest in the area receiving radiation. TNF-alpha is a potent cytokine that has been shown to have potent anti-cancer activities but, due to systemic toxicity, could not be delivered at effective doses. TNFerade™ is a novel way of selective delivery of TNF-alpha to tumor cells. TNFerade™ will be delivered once a week for five weeks by direct intratumoral injection by using endoscopy or Endoscopic Ultrasound. 5-FU (1000 mg/m2/day) will be delivered via continuous infusion for 96 hours during weeks 1 and 4. Cisplatin (75 mg/m2) will be delivered on Day 1 and Day 29 intravenously. The dose of radiation delivered will be 45 Gy in 1.8 Gy fractions for 5 weeks.
Interventions
- GENETIC TNFerade
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00051480
The ClinicalTrials.gov registry entry for NCT00051480 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is GenVec, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TNFerade is the first listed.
NCT00051480 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00051480 about?
NCT00051480 is a clinical study titled "Study of TNFerade™ Gene Therapy, Radiation, 5-FU and Cisplatin in Esophageal Cancer". The primary purpose of this study is to assess the safety and feasibility of giving TNFerade™ with 5-FU, Cisplatin and radiation therapy to patients with locally advanced, esophageal cancer prior to surgical resection. TNFerade™ is a replication deficient (E1, E3 and E4 deleted) adenovirus vector co...
What is the current status of trial NCT00051480?
This trial is currently completed. It is a Phase 2 study.
What interventions are being tested in trial NCT00051480?
The interventions under investigation include: TNFerade (GENETIC).
Who is sponsoring clinical trial NCT00051480?
This trial is sponsored by GenVec, which has 7 total clinical trials registered on ClinicalTrials.gov.
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