Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006483
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-11-06
Brief Title:
Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study Of Aerosolized GM-CSF In The Treatment Of Metastatic Renal Cell Carcinoma 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 increase the number of immune cells found in bone marrow or peripheral blood and may be an effective treatment for patients with kidney cancer that has spread to the lung
PURPOSE Phase II trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung
PURPOSE Phase II trial to study the effectiveness of sargramostim in treating patients who have kidney cancer that has spread to the lung
Detailed Description:
OBJECTIVES
Determine the 4-month progression-free survival rate and overall survival rate in patients with metastatic renal cell carcinoma to the lung treated with aerosolized sargramostim GM-CSF
Determine the toxicity of this regimen in these patients
Determine the immunomodulatory effects of this regimen in terms of natural killer cells cytotoxicity and T-cell B-cell and dendritic cell activation markers
OUTLINE This is a multicenter study
Patients receive aerosolized sargramostim GM-CSF by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21 Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity
Patients are followed for disease progression and then every 3 months thereafter
PROJECTED ACCRUAL A total of 21-48 patients will be accrued for this study within 7-20 months
Determine the 4-month progression-free survival rate and overall survival rate in patients with metastatic renal cell carcinoma to the lung treated with aerosolized sargramostim GM-CSF
Determine the toxicity of this regimen in these patients
Determine the immunomodulatory effects of this regimen in terms of natural killer cells cytotoxicity and T-cell B-cell and dendritic cell activation markers
OUTLINE This is a multicenter study
Patients receive aerosolized sargramostim GM-CSF by nebulizer over 10-15 minutes twice daily on days 1-7 and 14-21 Treatment repeats every 28 days in the absence of disease progression or unaceptable toxicity
Patients are followed for disease progression and then every 3 months thereafter
PROJECTED ACCRUAL A total of 21-48 patients will be accrued for this study within 7-20 months
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 |
|---|---|---|---|
| CDR0000068314 | REGISTRY | PDQ Physician Data Query | None |