Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004250
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-01-28
Brief Title:
Isolated Limb Infusion of Chemotherapy in Treating Patients With Melanoma or Soft Tissue Sarcoma of the Arm or Leg That Cannot Be Removed By Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Trial of Isolated Limb Infusion With Melphalan and Dactinomycin for Regional Melanoma and Soft Tissue Sarcoma of the Extremity
Status:
COMPLETED
Status Verified Date:
2013-01
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 use different ways to stop tumor cells from dividing so they stop growing or die Infusing chemotherapy to the tumor area only may kill more tumor cells and cause less damage to healthy tissues
PURPOSE This phase II trial is studying isolated limb infusion of chemotherapy to see how well it works in treating patients with melanoma or soft tissue sarcoma of the arm or leg that cannot be removed by surgery
PURPOSE This phase II trial is studying isolated limb infusion of chemotherapy to see how well it works in treating patients with melanoma or soft tissue sarcoma of the arm or leg that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Determine the efficacy of isolated limb infusion ILI with melphalan and dactinomycin in patients with primary or recurrent unresectable regional melanoma or soft tissue sarcoma of the extremity
Determine the morbidity of patients treated with this regimen
Determine the expression of melanoma-associated antigens as well as cellular and humoral immune responses to these antigens in patients with regional disease
OUTLINE Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity After the limb is warmed melphalan and dactinomycin are rapidly infused into the isolated limb via the arterial catheter Melphalan and dactinomycin are then recirculated for 20 minutes Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician
Patients are followed at 1-2 weeks 3-4 weeks 6-8 weeks and then every 3-6 months thereafter as deemed necessary by the treating physician
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within 3 years
Determine the efficacy of isolated limb infusion ILI with melphalan and dactinomycin in patients with primary or recurrent unresectable regional melanoma or soft tissue sarcoma of the extremity
Determine the morbidity of patients treated with this regimen
Determine the expression of melanoma-associated antigens as well as cellular and humoral immune responses to these antigens in patients with regional disease
OUTLINE Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity After the limb is warmed melphalan and dactinomycin are rapidly infused into the isolated limb via the arterial catheter Melphalan and dactinomycin are then recirculated for 20 minutes Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician
Patients are followed at 1-2 weeks 3-4 weeks 6-8 weeks and then every 3-6 months thereafter as deemed necessary by the treating physician
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| NCI-G99-1664 | None | None | None |
| MSKCC-99047 | None | None | None |