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COMPLETED Phase 2

GM-CSF as Adjuvant Therapy of Melanoma

NCT00350597 · View on ClinicalTrials.gov ↗

Study Summary

This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk for recurrence (Stage II T4, III and IV).

Conditions Studied

Interventions

  • DRUG Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)

Study Locations (1)

California

  • Northern California Melanoma Center — San Francisco

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2004-09
Est. Completion 2010-07
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00350597

The ClinicalTrials.gov registry entry for NCT00350597 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 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northern California Melanoma Center, which has 1 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 Malignant Melanoma appearing as the primary indexed condition, and to 1 intervention — of which Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) 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: NCT00350597 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 NCT00350597 about?

NCT00350597 is a clinical study titled "GM-CSF as Adjuvant Therapy of Melanoma". This is a pilot study to describe the immunological responses and clinical outcome associated with administration of recombinant human Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk for recurrence (Stage...

What is the current status of trial NCT00350597?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-09. Estimated completion is 2010-07.

What conditions does trial NCT00350597 study?

This clinical trial studies the following conditions: Malignant 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 NCT00350597?

The interventions under investigation include: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00350597?

This trial is sponsored by Northern California Melanoma Center, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00350597 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