Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085423
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2004-06-10
Brief Title:
Cyclophosphamide Fludarabine and High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
High Dose Interleukin-2 IL-2 Therapy In Lymphodepleted Primed Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 Drugs used in chemotherapy such as cyclophosphamide and fludarabine work in different ways to stop tumor cells from dividing so they stop growing or die Interleukin-2 may stimulate a persons white blood cells to kill tumor cells and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma
PURPOSE This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide fludarabine and high-dose interleukin-2
Determine the feasibility of this regimen in these patients
Secondary
Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen
Determine time to disease progression and survival in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days 1 and 2 and fludarabine IV over 30 minutes on days 3-7 Patients then receive high-dose interleukin-2 IV every 8 hours 14 doses on days 8-12 and 22-26 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 8 and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-33 patients will be accrued for this study
Primary
Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide fludarabine and high-dose interleukin-2
Determine the feasibility of this regimen in these patients
Secondary
Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen
Determine time to disease progression and survival in patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive lymphodepleting therapy comprising cyclophosphamide IV over 1 hour on days 1 and 2 and fludarabine IV over 30 minutes on days 3-7 Patients then receive high-dose interleukin-2 IV every 8 hours 14 doses on days 8-12 and 22-26 Patients also receive sargramostim GM-CSF subcutaneously beginning on day 8 and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-33 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 |
|---|---|---|---|
| P30CA023108 | NIH | None | None |
| DMS-0320 | OTHER | None | None |
| DMS-16531 | OTHER | Dartmouth-Hitchcock | httpsreporternihgovquickSearchP30CA023108 |