Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001577
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
Status:
COMPLETED
Status Verified Date:
1999-04
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:
Hyperthermic isolated limb perfusion with melphalan alone is administered as a double perfusion schedule
These two isolates limb perfusions with melphalan are treated 3-6 weeks apart After perfusion is established the leak rate has been determined to be acceptable and tissue temperatures are 38 degrees Celsius then the melphalan is administered by slow injection into an arterial line over approximately 5 minutes The perfusion with melphalan will then continue for 60 minutes after which the extremity is flushed out with a total of 3 liters of fluid consisting initially of a saline solution The dose of melphalan for the second perfusion will be increased
An attempt to resect the residual lesion between 6-12 weeks after the second
interval perfusion may be made
These two isolates limb perfusions with melphalan are treated 3-6 weeks apart After perfusion is established the leak rate has been determined to be acceptable and tissue temperatures are 38 degrees Celsius then the melphalan is administered by slow injection into an arterial line over approximately 5 minutes The perfusion with melphalan will then continue for 60 minutes after which the extremity is flushed out with a total of 3 liters of fluid consisting initially of a saline solution The dose of melphalan for the second perfusion will be increased
An attempt to resect the residual lesion between 6-12 weeks after the second
interval perfusion may be made
Detailed Description:
Patients with extremity melanoma Stage IIIA IIIAB or Stage IV disease who have bulky symptomatic tumor located in the extremity or patients with unresectable extremity sarcoma will undergo a double isolated limb perfusion with melphalan alone separated by approximately 4 to 6 weeks The initial perfusion will be done with a melphalan dose of 6 mgL limb volume and the interval perfusion with a dose of 9 mgL limb volume For patients with extremity sarcoma the tumor will be excised if feasible using a limb sparing resection between 6-12 weeks after the second perfusion Technical feasibility of the double perfusion schedule will be determined Overall response duration of response patterns of recurrence and survival will be followed
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 |
|---|---|---|---|
| 97-C-0131 | None | None | None |