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NCT00031733 · ClinicalTrials.gov registry record · Phase 2

Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

A Phase 2 study of Melanoma (Skin) and Intraocular Melanoma, sponsored by University of Southern California.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT00031733 is a Phase 2 study of Melanoma (Skin) and Intraocular Melanoma that has completed, run by University of Southern California. The registered enrollment target is 60 participants, below the 135-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00031733, a Phase 2 study of Melanoma (Skin) and Intraocular Melanoma, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Interventions

  • BIOLOGICAL sargramostim
  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL recombinant interleukin-12
  • BIOLOGICAL gp100 antigen
  • BIOLOGICAL MART-1 antigen

Study Locations (1)

California

  • USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2002-02
Est. Completion 2007-11
Phase Phase 2

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT00031733

The ClinicalTrials.gov registry entry for NCT00031733 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (56% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which sargramostim is the first listed.

NCT00031733 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00031733 about?

NCT00031733 is a clinical study titled "Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma". RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-1...

What is the current status of trial NCT00031733?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2002-02. Estimated completion is 2007-11.

What conditions does trial NCT00031733 study?

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

What interventions are being tested in trial NCT00031733?

The interventions under investigation include: sargramostim (BIOLOGICAL), incomplete Freund's adjuvant (BIOLOGICAL), recombinant interleukin-12 (BIOLOGICAL), gp100 antigen (BIOLOGICAL), MART-1 antigen (BIOLOGICAL).

Who is sponsoring clinical trial NCT00031733?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00031733 being conducted?

This trial has 1 study location across California. 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.