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NCT00961376 · ClinicalTrials.gov registry record · Phase 2
Vaccination of Melanoma Patients With Total or CD25-depleted Peripheral Blood Mononuclear Cell (PBMC)
A Phase 2 study, sponsored by Providence Health & Services.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00961376 is a Phase 2 study that was terminated before completion, run by Providence Health & Services. The registered enrollment target is 5 participants.
The verdict
NCT00961376, a Phase 2 study, was terminated before completion, sponsored by Providence Health & Services.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and immunologic effects of autologous tumor vaccination administered with human granulocyte-macrophage colony-simulating factor (hGM-CSF), and subsequent boosting vaccinations in patients made lymphopenic by treatment with chemotherapy and infused with autologous PBMC (Cohort A) or CD25 depleted PBMC (Cohort B). Clinical observations and laboratory measurements will be monitored to evaluate safety, toxicity, immune responses, and anti-tumor effects. Additionally, the effects of treatment on tumor response will be evaluated.
Interventions
- BIOLOGICAL PBMC re-infusion
- BIOLOGICAL CD25 depletion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2009-07 |
| Est. Completion | 2015-02-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00961376
The ClinicalTrials.gov registry entry for NCT00961376 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Providence Health & Services, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PBMC re-infusion is the first listed.
NCT00961376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00961376 about?
NCT00961376 is a clinical study titled "Vaccination of Melanoma Patients With Total or CD25-depleted Peripheral Blood Mononuclear Cell (PBMC)". The objective of this study is to evaluate the safety and immunologic effects of autologous tumor vaccination administered with human granulocyte-macrophage colony-simulating factor (hGM-CSF), and subsequent boosting vaccinations in patients made lymphopenic by treatment with chemotherapy and infuse...
What is the current status of trial NCT00961376?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2009-07. Estimated completion is 2015-02-10.
What interventions are being tested in trial NCT00961376?
The interventions under investigation include: PBMC re-infusion (BIOLOGICAL), CD25 depletion (BIOLOGICAL).
Who is sponsoring clinical trial NCT00961376?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
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