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NCT00228358 · ClinicalTrials.gov registry record · Phase 1
Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00228358 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 8 participants.
The verdict
NCT00228358, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This phase I trial studies the safety and the ability to expand laboratory-treated T cells when given together with cyclophosphamide or denileukin diftitox in treating patients with human epidermal growth factor receptor (HER)-2/neu overexpressing metastatic breast cancer, ovarian cancer, or non-small cell lung cancer previously treated with HER-2/neu vaccine. Laboratory-expanded T cells may help the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as denileukin diftitox, may stimulate the immune system in different ways and stop tumor cells from growing. Giving laboratory-treated T cells together with cyclophosphamide or denileukin diftitox may allow the immune system to kill more tumor cells
Interventions
- DRUG cyclophosphamide
- OTHER flow cytometry
- OTHER immunoenzyme technique
- BIOLOGICAL denileukin diftitox
- DRUG ex vivo-expanded HER2-specific T cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2003-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00228358
The ClinicalTrials.gov registry entry for NCT00228358 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00228358 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00228358 about?
NCT00228358 is a clinical study titled "Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine". This phase I trial studies the safety and the ability to expand laboratory-treated T cells when given together with cyclophosphamide or denileukin diftitox in treating patients with human epidermal growth factor receptor (HER)-2/neu overexpressing metastatic breast cancer, ovarian cancer, or non-sma...
What is the current status of trial NCT00228358?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2003-06.
What interventions are being tested in trial NCT00228358?
The interventions under investigation include: cyclophosphamide (DRUG), flow cytometry (OTHER), immunoenzyme technique (OTHER), denileukin diftitox (BIOLOGICAL), ex vivo-expanded HER2-specific T cells (DRUG).
Who is sponsoring clinical trial NCT00228358?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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