NCT00017121

Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung

Dose Finding Study of Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * Determine immunomodulatory effects of aerosolized sargramostim (GM-CSF) in patients with metastatic melanoma to the lung (part A). * Determine toxicity profile of this therapy, in terms of pulmonary and hematologic toxicity, in these patients. * Determine, preliminarily, the therapeutic effects of this therapy, in terms of progression-free survival, overall survival, and objective response rate, in these patients. * Determine the maximum tolerated dose of GM-CSF in these patients (part B). OUTLINE: This is a dose-escalation, multicenter study. Patients receive aerosolized sargramostim (GM-CSF) twice a day on days 1-7 and 15-21. Treatment repeats every 28 days for 2 courses. Patients with no disease progression after completion of course 2 may continue on treatment until disease progression. Patients are grouped to 1 of 2 dose-escalation regimens (part A vs B). * Part A: Cohorts of 5-10 patients receive escalating doses of GM-CSF until the optimal immunostimulatory dose (ISD) is determined. The optimal ISD is defined as the dose at which at least 7 of 10 patients experience immunostimulation. Once the optimal ISD is determined, 10 patients receive aerosolized GM-CSF at a dose halfway between the optimal ISD and the preceding dose. Dose escalation is discontinued if at least 2 of 5 or at least 4 of 10 patients on a particular dose level experience dose-limiting toxicity. * Part B: Cohorts of 3-6 patients receive escalating doses of GM-CSF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. After completion of study therapy, patients are followed at 3 months, every 2 months for 1 year, and then every 3-4 months for 5 years. PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.

Conditions

• Melanoma (Skin)
• Metastatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim

Timeline

• Start date: 2002-05-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

87 sites across 1 country: United States