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NCT00001577 · ClinicalTrials.gov registry record · Phase 1

Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

A Phase 1 study of Melanoma and Sarcoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT00001577 is a Phase 1 study of Melanoma and Sarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001577, a Phase 1 study of Melanoma and Sarcoma, has completed, sponsored by National Cancer Institute (NCI).

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

Study Summary

Hyperthermic isolated limb perfusion with melphalan alone is administered as a double perfusion schedule. These two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After perfusion is established, the leak rate has been determined to be acceptable, and tissue temperatures are 38 degrees Celsius, then the melphalan is administered by slow injection into an arterial line over approximately 5 minutes. The perfusion with melphalan will then continue for 60 minutes, after which the extremity is flushed out with a total of 3 liters of fluid consisting initially of a saline solution. The dose of melphalan for the second perfusion will be increased. An attempt to resect the residual lesion between 6-12 weeks after the second interval perfusion may be made.

Conditions Studied

Interventions

  • PROCEDURE double isolated limb perfusion with melphalan alone

Study Locations (1)

Maryland

  • National Cancer Institute (NCI) - Bethesda

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 1997-06
Est. Completion 2000-03
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00001577

The ClinicalTrials.gov registry entry for NCT00001577 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which double isolated limb perfusion with melphalan alone is the first listed.

NCT00001577 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001577 about?

NCT00001577 is a clinical study titled "Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity". Hyperthermic isolated limb perfusion with melphalan alone is administered as a double perfusion schedule. These two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After perfusion is established, the leak rate has been determined to be acceptable, and tissue temperatures are 38...

What is the current status of trial NCT00001577?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 1997-06. Estimated completion is 2000-03.

What conditions does trial NCT00001577 study?

This clinical trial studies the following conditions: Melanoma, Sarcoma.

What interventions are being tested in trial NCT00001577?

The interventions under investigation include: double isolated limb perfusion with melphalan alone (PROCEDURE).

Who is sponsoring clinical trial NCT00001577?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001577 being conducted?

This trial has 1 study location across Maryland. 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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