Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017121
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-06-06
Brief Title:
Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Dose Finding Study of Aerosolized GM-CSF in the Treatment of Metastatic Melanoma to the Lung
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068654 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02385 | REGISTRY | None | None |