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NCT00031564 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00031564: Completed Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00031564 is a Phase 2 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00031564, a Phase 2 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer.
Primary Outcome
The primary objective of this phase II trial involving 30 patients will be to determine tumor response rates. The immunogenicity of the treatment will be assessed by ELISPOT assays performed on the patients' peripheral blood lymphocytes, and by an immunohistochemical analysis of DTH skin tests site biopsies performed 48 hours after the intradermal injection of autologous, unmodified tumor cells.
Interventions
- BIOLOGICAL Interleukin-2
- BIOLOGICAL B7-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2000-05 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT00031564 record still lists
NCT00031564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which Interleukin-2 is the first listed.
NCT00031564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00031564 about?
NCT00031564 is a clinical study titled "Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2". RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor ...
What is the current status of trial NCT00031564?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2000-05. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00031564?
The interventions under investigation include: Interleukin-2 (BIOLOGICAL), B7-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00031564?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00031564's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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