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NCT01989559 · ClinicalTrials.gov registry record · Phase 1
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01989559: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01989559 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989559, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
Primary Outcome
Characterized using three different in vitro assays. Fresh and cryopreserved peripheral blood mononuclear cells (PBMC) will be analyzed for gp100 peptide-specific CD8+ T cells using a fluorescinated, modified gp100, peptide-specific, A2-restricted tetramer binding assay and the interferon (IFN) gamma specific enzyme-linked immunosorbent spot (ELISPOT) and cytokine flow cytometry (CFC) assays.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL gp100:209-217(210M) Peptide Vaccine
- BIOLOGICAL HPV 16 E7:12-20 Peptide Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-10 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
What the finished NCT01989559 record still lists
NCT01989559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01989559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989559 about?
NCT01989559 is a clinical study titled "Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery". This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations m...
What is the current status of trial NCT01989559?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2002-10. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01989559?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), gp100:209-217(210M) Peptide Vaccine (BIOLOGICAL), HPV 16 E7:12-20 Peptide Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01989559?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989559's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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