Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Dose Finding Study of Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung|
- Extent of up-regulation of specific anti-melanoma T cell frequencies (part A) [ Designated as safety issue: No ]
- Maximum tolerated dose (part B) [ Designated as safety issue: Yes ]
- Toxicity profile [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Objective response rate [ Designated as safety issue: No ]
- Percent change from pretreatment levels in other immune parameters [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017121
Show 87 Study Locations
|Study Chair:||Svetomir Markovic, MD, PhD||Mayo Clinic|
|Investigator:||John H. Donohue, MD||Mayo Clinic|
|Investigator:||Ellison F. Kalda, MD, FACS||Avera Cancer Institute|
|Investigator:||Lawrence J. Burgart, MD||Mayo Clinic|
|Investigator:||Axel Grothey, MD||Mayo Clinic|
|Investigator:||Muhammed Hussain, MD||Saskatchewan Cancer Agency|