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NCT00071981 · ClinicalTrials.gov registry record · Phase 2

Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

A Phase 2 study, sponsored by Eastern Cooperative Oncology Group.

Completed
Registry status
Phase 2
Development phase
175
Enrollment target

NCT00071981: Completed Phase 2 study, sponsored by Eastern Cooperative Oncology Group.

NCT00071981 is a Phase 2 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 175 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00071981, a Phase 2 study, has completed, sponsored by Eastern Cooperative Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
175 participants
Enrollment target

Study Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma.

Primary Outcome

Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.

Interventions

  • BIOLOGICAL sargramostim
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL melanoma helper peptide vaccine
  • BIOLOGICAL multi-epitope melanoma peptide vaccine
  • BIOLOGICAL tetanus peptide melanoma vaccine

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2005-05-09
Est. Completion 2014-01
Phase Phase 2
Eastern Cooperative Oncology Group

141 total trials

What the finished NCT00071981 record still lists

NCT00071981 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher).

The record links to 0 conditions, and to 5 interventions - of which sargramostim is the first listed.

NCT00071981 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00071981 about?

NCT00071981 is a clinical study titled "Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma". RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with me...

What is the current status of trial NCT00071981?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2005-05-09. Estimated completion is 2014-01.

What interventions are being tested in trial NCT00071981?

The interventions under investigation include: sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), melanoma helper peptide vaccine (BIOLOGICAL), multi-epitope melanoma peptide vaccine (BIOLOGICAL), tetanus peptide melanoma vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00071981?

This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00071981's enrollment target sits among peer trials

175 396th of 2000 higher than 1,605 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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Source: ClinicalTrials.gov NCT00071981, the US trial registry maintained by the National Library of Medicine. NCT00071981 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.