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NCT00565968 · ClinicalTrials.gov registry record · Phase 1

Sorafenib and Isolated Limb Infusion of Melphalan in Treating Patients With Stage III Melanoma of the Arm or Leg

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

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT00565968 is a Phase 1 study of Melanoma (Skin) that has completed, run by Duke University. The registered enrollment target is 20 participants, below the 136-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00565968, a Phase 1 study of Melanoma (Skin), has completed, sponsored by Duke University.

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

Study Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may also make tumor cells more sensitive to melphalan. Giving sorafenib together with an isolated limb infusion of melphalan may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with an isolated limb infusion of melphalan in treating patients with stage III melanoma of the arm or leg.

Conditions Studied

Interventions

  • GENETIC gene expression analysis
  • GENETIC protein expression analysis
  • DRUG melphalan
  • GENETIC western blotting
  • DRUG sorafenib tosylate

Study Locations (1)

New York

  • Memorial Sloan-Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-10
Phase Phase 1

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT00565968

The ClinicalTrials.gov registry entry for NCT00565968 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 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 (85% lower). The listed sponsor is Duke University, which has 1,725 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 gene expression analysis is the first listed.

NCT00565968 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00565968 about?

NCT00565968 is a clinical study titled "Sorafenib and Isolated Limb Infusion of Melphalan in Treating Patients With Stage III Melanoma of the Arm or Leg". RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping ...

What is the current status of trial NCT00565968?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2007-10.

What conditions does trial NCT00565968 study?

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

What interventions are being tested in trial NCT00565968?

The interventions under investigation include: gene expression analysis (GENETIC), protein expression analysis (GENETIC), melphalan (DRUG), western blotting (GENETIC), sorafenib tosylate (DRUG).

Who is sponsoring clinical trial NCT00565968?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00565968 being conducted?

This trial has 1 study location across New York. 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

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