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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: Clinical Trial Phase 2 study, sponsored by Providence Health & Services.
NCT00961376 is a Phase 2 study that was terminated before completion, run by Providence Health & Services. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The absolute number and frequency of tumor specific T cells will be measured at days 7, 21, 35, 64, 91, and day 119.
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 |
Why NCT00961376 stopped before completion
NCT00961376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which PBMC re-infusion is the first listed.
NCT00961376 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00961376's enrollment target sits among peer trials
5 2000th 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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