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NCT01355393 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01355393 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 50 participants.
The verdict
NCT01355393, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies, such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary treatment to lower the risk that the cancer will come back and are one way to help vaccines produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or GM-CSF may be a safe and effective treatment for breast cancer.
Interventions
- BIOLOGICAL sargramostim
- BIOLOGICAL HER-2/neu peptide vaccine
- DRUG rintatolimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01355393
The ClinicalTrials.gov registry entry for NCT01355393 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 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 3 interventions - of which sargramostim is the first listed.
NCT01355393 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01355393 about?
NCT01355393 is a clinical study titled "Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer". This randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines m...
What is the current status of trial NCT01355393?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-07.
What interventions are being tested in trial NCT01355393?
The interventions under investigation include: sargramostim (BIOLOGICAL), HER-2/neu peptide vaccine (BIOLOGICAL), rintatolimod (DRUG).
Who is sponsoring clinical trial NCT01355393?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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