Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085579
Status:
WITHDRAWN
Last Update Posted:
2012-12-12
First Post:
2004-06-10
Brief Title:
Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy
Status:
WITHDRAWN
Status Verified Date:
2012-12
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 Interleukin-2 and sargramostim may stimulate a persons white blood cells to kill melanoma cells
PURPOSE This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy
PURPOSE This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy
Detailed Description:
OBJECTIVES
Primary
Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim GM-CSF
Secondary
Determine the time to progression in patients treated with this regimen
Determine the effects of this regimen on lymphocyte subsets in these patients
OUTLINE Patients are stratified according to response to prior systemic chemotherapy stable disease SD vs partial response PR
Patients receive sargramostim GM-CSF subcutaneously SC on days 1-14 and low-dose interleukin-2 IL-2 SC on days 1-5 8-12 15-19 and 22-26 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients also receive pulses of high-dose IL-2 IV continuously over 42 hours on days 1 and 2 of courses 2 3 5 6 8 10 and 12
NOTE Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration
Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course
PROJECTED ACCRUAL A total of 20-58 patients 10-29 per stratum will be accrued for this study
Primary
Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim GM-CSF
Secondary
Determine the time to progression in patients treated with this regimen
Determine the effects of this regimen on lymphocyte subsets in these patients
OUTLINE Patients are stratified according to response to prior systemic chemotherapy stable disease SD vs partial response PR
Patients receive sargramostim GM-CSF subcutaneously SC on days 1-14 and low-dose interleukin-2 IL-2 SC on days 1-5 8-12 15-19 and 22-26 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients also receive pulses of high-dose IL-2 IV continuously over 42 hours on days 1 and 2 of courses 2 3 5 6 8 10 and 12
NOTE Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration
Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course
PROJECTED ACCRUAL A total of 20-58 patients 10-29 per stratum will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-04027 | None | None | None |