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COMPLETED Phase 2

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

NCT00031733 · View on ClinicalTrials.gov ↗

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

412 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00031733

The ClinicalTrials.gov registry entry for NCT00031733 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00031733 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00031733?

This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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