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NCT00003224 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy in Treating Patients With Metastatic Melanoma

A Phase 1 study of Melanoma (Skin), sponsored by University of Virginia.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target
1
Study location

NCT00003224 is a Phase 1 study of Melanoma (Skin) that has completed, run by University of Virginia. The registered enrollment target is 22 participants, below the 136-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00003224, a Phase 1 study of Melanoma (Skin), has completed, sponsored by University of Virginia.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.

Conditions Studied

Melanoma (Skin)

Interventions

  • BIOLOGICAL QS21
  • BIOLOGICAL IFA (incomplete Freund's adjuvant)
  • BIOLOGICAL p946
  • BIOLOGICAL p946/tet-p
  • BIOLOGICAL Tet-p

Study Locations (1)

Virginia

  • Cancer Center, University of Virginia HSC - Charlottesville

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 1996-02
Phase Phase 1

Sponsor

University of Virginia

449 total trials

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What the Registry Record Tells You About NCT00003224

The ClinicalTrials.gov registry entry for NCT00003224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 136-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (84% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which QS21 is the first listed.

NCT00003224 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT00003224 about?

NCT00003224 is a clinical study titled "Vaccine Therapy in Treating Patients With Metastatic Melanoma". RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. PURPOSE: Randomized phase I t...

What is the current status of trial NCT00003224?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 1996-02.

What conditions does trial NCT00003224 study?

This clinical trial studies the following conditions: Melanoma (Skin).

What interventions are being tested in trial NCT00003224?

The interventions under investigation include: QS21 (BIOLOGICAL), IFA (incomplete Freund's adjuvant) (BIOLOGICAL), p946 (BIOLOGICAL), p946/tet-p (BIOLOGICAL), Tet-p (BIOLOGICAL).

Who is sponsoring clinical trial NCT00003224?

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

Where is trial NCT00003224 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.