drugset / Trial / NCT00017121

Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

NCT00017121 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Inhaling sargramostim may interfere with the growth of tumor cells and may be an effective treatment for melanoma that has spread to the lung. PURPOSE: This phase I trial is studying the side effects and best dose of inhaled sargramostim in treating patients with melanoma that is metastatic to the lung.

Timeline

Start
2002-05
Primary completion
2012-11
Completion
2012-11

Outcome

Missed primary endpoint

paper A dose of aerosolized GM-CSF capable of inducing antitumor immunity in the majority of patients was not reached. PMID 19060590 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject sargramostim Protein / enzyme biologic 500 ug Inhaled
Subject sargramostim Protein / enzyme biologic 750 ug Inhaled
Subject sargramostim Protein / enzyme biologic 1000 ug Inhaled
Subject sargramostim Protein / enzyme biologic 1250 ug Inhaled
Subject sargramostim Protein / enzyme biologic 1500 ug Inhaled
Subject sargramostim Protein / enzyme biologic 1750 ug Inhaled
Subject sargramostim Protein / enzyme biologic 2000 ug Inhaled