Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003789
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
1999-11-01
Brief Title:
Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion and Melphalan With and Without Tumor Necrosis Factor in Patients With Localized Advanced Extremity Melanoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have locally advanced melanoma of the arm or leg Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Heating melphalan to several degrees above body temperature and infusing it only to the area around the tumor may kill more tumor cells It is not yet known whether combining melphalan with tumor necrosis factor is more effective than melphalan alone in treating melanoma
Detailed Description:
OBJECTIVES
I Compare hyperthermic isolated limb perfusion with melphalan with or without tumor necrosis factor in terms of response proportion for lesions in the perfusion field in patients with locally advanced extremity melanoma
II Compare the local recurrence-free survival improvement in regional symptoms related to tumor and overall survival in patients treated with these regimens
III Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor burden high vs low prior reperfusion melphalan vs other regional nodal site yes vs no and participating center Patients are randomized to one of two treatment arms
ARM I Patients undergo hyperthermic isolated perfusions of the lower limb by either the external iliac vessels or the common femoral vessels Patients undergo perfusions of the upper extremity by the axillary artery and vein using an infraclavicularaxillary incision Melphalan is introduced into the perfusion by slow injection over 5 minutes and allowed to remain for a total of 60 minutes
ARM II Patients undergo hyperthermic isolated perfusions as in arm I Tumor necrosis factor is administered by slow injection into the arterial line and allowed to remain for a total of 90 minutes Melphalan is introduced into the perfusion as in arm I and allowed to remain for a total of 60 minutes
Patients are followed within 6 weeks at 3 6 and 12 months every 6 months for 4 years and then annually thereafter
I Compare hyperthermic isolated limb perfusion with melphalan with or without tumor necrosis factor in terms of response proportion for lesions in the perfusion field in patients with locally advanced extremity melanoma
II Compare the local recurrence-free survival improvement in regional symptoms related to tumor and overall survival in patients treated with these regimens
III Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor burden high vs low prior reperfusion melphalan vs other regional nodal site yes vs no and participating center Patients are randomized to one of two treatment arms
ARM I Patients undergo hyperthermic isolated perfusions of the lower limb by either the external iliac vessels or the common femoral vessels Patients undergo perfusions of the upper extremity by the axillary artery and vein using an infraclavicularaxillary incision Melphalan is introduced into the perfusion by slow injection over 5 minutes and allowed to remain for a total of 60 minutes
ARM II Patients undergo hyperthermic isolated perfusions as in arm I Tumor necrosis factor is administered by slow injection into the arterial line and allowed to remain for a total of 90 minutes Melphalan is introduced into the perfusion as in arm I and allowed to remain for a total of 60 minutes
Patients are followed within 6 weeks at 3 6 and 12 months every 6 months for 4 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA076001 | NIH | None | httpsreporternihgovquickSearchU10CA076001 |
| Z0020 | None | None | None |
| ACOSOG-Z0020 | None | None | None |
| CDR0000066929 | None | None | None |
| NCI-03-C-0137 | None | None | None |