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COMPLETED Phase 2

Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma

NCT00077532 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma. PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.

Conditions Studied

Interventions

  • BIOLOGICAL incomplete Freund's adjuvant
  • BIOLOGICAL gp100 antigen
  • BIOLOGICAL ipilimumab

Study Locations (1)

Maryland

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support — Bethesda

Trial Details

FieldValue
Enrollment Target 179 participants
Start Date 2004-03
Est. Completion 2008-02
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00077532

The ClinicalTrials.gov registry entry for NCT00077532 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 179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 209 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 3 interventions — of which incomplete Freund's adjuvant 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: NCT00077532 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. 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 NCT00077532 about?

NCT00077532 is a clinical study titled "Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma". RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a strong...

What is the current status of trial NCT00077532?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 179 participants. The study started on 2004-03. Estimated completion is 2008-02.

What conditions does trial NCT00077532 study?

This clinical trial studies the following conditions: Melanoma (Skin). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00077532?

The interventions under investigation include: incomplete Freund's adjuvant (BIOLOGICAL), gp100 antigen (BIOLOGICAL), ipilimumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00077532?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 209 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00077532 being conducted?

This trial has 1 study location across Maryland. 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