Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005610
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-05-02
Brief Title:
Study of Aerosolized 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:
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 Colony-stimulating factors such as sargramostim may help the bodys immune system to kill cancer cells Giving sargramostim in different ways may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of sargramostim given as a breathing treatment for treating patients who have melanoma that is metastatic to the lung
PURPOSE Phase II trial to study the effectiveness of sargramostim given as a breathing treatment for treating patients who have melanoma that is metastatic to the lung
Detailed Description:
OBJECTIVES I Determine the therapeutic effects of aerosolized sargramostim GM-CSF in terms of progression free survival at 2 months and median survival rate in patients with metastatic melanoma to the lung II Determine the immunomodulatory effects of this treatment regimen in this patient population III Assess the quality of life in terms of physical and personal concerns of these patients treated with this regimen
OUTLINE Patients receive aerosolized sargramostim GM-CSF over 10-15 minutes twice daily for 7 days Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and prior to course 5 Patients are followed every 2 months for at least 15 years
OUTLINE Patients receive aerosolized sargramostim GM-CSF over 10-15 minutes twice daily for 7 days Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline and prior to course 5 Patients are followed every 2 months for at least 15 years
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 |
|---|---|---|---|
| CDR0000067739 | REGISTRY | PDQ Physician Data Query | None |