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NCT00089219 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma

A Phase 1 study, sponsored by University of Virginia.

Completed
Registry status
Phase 1
Development phase
39
Enrollment target

NCT00089219: Completed Phase 1 study, sponsored by University of Virginia.

NCT00089219 is a Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 39 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00089219, a Phase 1 study, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
Phase 1
Development phase
39 participants
Enrollment target

Study Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

Primary Outcome

Toxicities measured by CTCAE.

Interventions

  • BIOLOGICAL GM-CSF
  • BIOLOGICAL 6MHP
  • BIOLOGICAL IFA

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2003-07
Phase Phase 1
University of Virginia

449 total trials

What the finished NCT00089219 record still lists

NCT00089219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% lower).

The record links to 0 conditions, and to 3 interventions - of which GM-CSF is the first listed.

NCT00089219 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00089219 about?

NCT00089219 is a clinical study titled "Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma". RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

What is the current status of trial NCT00089219?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2003-07.

What interventions are being tested in trial NCT00089219?

The interventions under investigation include: GM-CSF (BIOLOGICAL), 6MHP (BIOLOGICAL), IFA (BIOLOGICAL).

Who is sponsoring clinical trial NCT00089219?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00089219's enrollment target sits among peer trials

39 1191st of 2000 higher than 804 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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Source: ClinicalTrials.gov NCT00089219, the US trial registry maintained by the National Library of Medicine. NCT00089219 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.