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NCT00019682 · ClinicalTrials.gov registry record · Phase 3
Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
NCT00019682: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00019682 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00019682, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
Study Summary
This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.
Primary Outcome
A complete response (CR) was defined as the disappearance of all clinical evidence of disease for at least 4 weeks. A partial response (PR) was defined as a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions could appear, and none could increase 25% or more.
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BIOLOGICAL Aldesleukin
- DRUG Montanide ISA 51 VG
- BIOLOGICAL gp100 Antigen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 1999-12 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00019682 record still lists
NCT00019682 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT00019682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00019682 about?
NCT00019682 is a clinical study titled "Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma". This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person'...
What is the current status of trial NCT00019682?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 1999-12. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00019682?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Aldesleukin (BIOLOGICAL), Montanide ISA 51 VG (DRUG), gp100 Antigen (BIOLOGICAL).
Who is sponsoring clinical trial NCT00019682?
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 NCT00019682's enrollment target sits among peer trials
185 1417th of 2000 higher than 583 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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