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NCT00704938 · ClinicalTrials.gov registry record · Phase 2
Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00704938: Clinical Trial Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00704938 is a Phase 2 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00704938, a Phase 2 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.
Primary Outcome
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL aldesleukin
- BIOLOGICAL filgrastim
- BIOLOGICAL autologous dendritic cell-adenovirus p53 vaccine
- BIOLOGICAL anti-p53 T-cell receptor-transduced peripheral blood lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
Why NCT00704938 stopped before completion
NCT00704938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00704938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00704938 about?
NCT00704938 is a clinical study titled "Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer". RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective ...
What is the current status of trial NCT00704938?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2008-06. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00704938?
The interventions under investigation include: cyclophosphamide (DRUG), aldesleukin (BIOLOGICAL), filgrastim (BIOLOGICAL), autologous dendritic cell-adenovirus p53 vaccine (BIOLOGICAL), anti-p53 T-cell receptor-transduced peripheral blood lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00704938?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00704938's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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