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NCT00004070 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00004070: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT00004070 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004070, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.
Primary Outcome
The MTD of IL-12 gene medicine is determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed in the two dose levels planned then evaluation of a third escalation will be considered. If the MTD is not reached, the dose selected for use in the phase II portion will be defined as the maximum volume that can be reasonably and safely injected into the
Interventions
- BIOLOGICAL IL-12
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 1999-07 |
| Est. Completion | 2000-12 |
| Phase | Phase 1 |
What the finished NCT00004070 record still lists
NCT00004070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which IL-12 is the first listed.
NCT00004070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004070 about?
NCT00004070 is a clinical study titled "Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer". Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.
What is the current status of trial NCT00004070?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 1999-07. Estimated completion is 2000-12.
What interventions are being tested in trial NCT00004070?
The interventions under investigation include: IL-12 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00004070?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004070's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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