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NCT00791037 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Treating Patients With Stage IV Breast Cancer
A Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00791037: Completed Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, sponsored by University of Washington.
NCT00791037 is a Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer that has completed, run by University of Washington. The registered enrollment target is 23 participants, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00791037, a Phase 1 study of HER2-positive Breast Cancer and Stage IV Breast Cancer, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)
Primary Outcome
Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding t
Conditions Studied
Interventions
- DRUG cyclophosphamide
- PROCEDURE leukapheresis
- BIOLOGICAL sargramostim
- BIOLOGICAL HER-2/neu peptide vaccine
- BIOLOGICAL ex vivo-expanded HER2-specific T cells
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT00791037 record still lists
NCT00791037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00791037 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT00791037 about?
NCT00791037 is a clinical study titled "Vaccine Therapy in Treating Patients With Stage IV Breast Cancer". This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cel...
What is the current status of trial NCT00791037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2008-10. Estimated completion is 2014-12.
What conditions does trial NCT00791037 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Stage IV Breast Cancer, Recurrent Breast Cancer, Male Breast Cancer.
What interventions are being tested in trial NCT00791037?
The interventions under investigation include: cyclophosphamide (DRUG), leukapheresis (PROCEDURE), sargramostim (BIOLOGICAL), HER-2/neu peptide vaccine (BIOLOGICAL), ex vivo-expanded HER2-specific T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00791037?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00791037 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00791037's enrollment target sits among peer trials
23 50th of 58 higher than 8 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer 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.
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