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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: Completed Phase 2 study, sponsored by GenVec.
NCT00051480 is a Phase 2 study that has completed, run by GenVec. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00051480 record still lists
NCT00051480 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which TNFerade is the first listed.
NCT00051480 does not publish any study locations in the registry export this page uses.
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.