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NCT00671554 · ClinicalTrials.gov registry record · Phase 1

Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma

A Phase 1 study, sponsored by Prisma Health-Upstate.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT00671554: Clinical Trial Phase 1 study, sponsored by Prisma Health-Upstate.

NCT00671554 is a Phase 1 study that was terminated before completion, run by Prisma Health-Upstate. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00671554, a Phase 1 study, was terminated before completion, sponsored by Prisma Health-Upstate.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.

Primary Outcome

Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.

Interventions

  • BIOLOGICAL Melaxin (autologous dendritoma vaccine) and BCG

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2008-04
Est. Completion 2009-03
Phase Phase 1
Prisma Health-Upstate

67 total trials

Why NCT00671554 stopped before completion

NCT00671554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Melaxin (autologous dendritoma vaccine) and BCG is the first listed.

NCT00671554 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00671554 about?

NCT00671554 is a clinical study titled "Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma". The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.

What is the current status of trial NCT00671554?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2008-04. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00671554?

The interventions under investigation include: Melaxin (autologous dendritoma vaccine) and BCG (BIOLOGICAL).

Who is sponsoring clinical trial NCT00671554?

This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00671554's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 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 NCT00671554, the US trial registry maintained by the National Library of Medicine. NCT00671554 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.