Isolated Limb Perfusion of Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Soft Tissue Sarcoma of the Arm or Leg
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00019968|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : March 15, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing melphalan directly to the tumor may kill more tumor cells and cause less damage to healthy tissues. It is not yet known whether melphalan plus tumor necrosis factor is more effective than melphalan alone for soft tissue sarcoma.
PURPOSE: Randomized phase II trial to study the effectiveness of isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have soft tissue sarcoma of the arm or leg.
|Condition or disease||Intervention/treatment||Phase|
|Stage IVB Adult Soft Tissue Sarcoma Stage IIB Adult Soft Tissue Sarcoma Stage IIC Adult Soft Tissue Sarcoma Recurrent Adult Soft Tissue Sarcoma Stage IVA Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma||Drug: melphalan Drug: tumor necrosis factor||Phase 2|
OBJECTIVES: I. Determine the response rates, duration of response, patterns of recurrence and overall survival in patients with unresectable high grade soft tissue sarcomas of the extremity following isolated limb perfusion (ILP) using melphalan with or without tumor necrosis factor (TNF).
II. Determine the application of these regimens as neoadjuvant therapy to render an unresectable sarcoma resectable.
III. Determine whether either regimen results in durable disease control and limb salvage for patients with multifocal unresectable high grade soft tissue sarcoma of the extremity or patients with stage IV soft tissue sarcoma with symptomatic primary extremity tumor.
PROTOCOL OUTLINE: This is a randomized study.
Patients are randomized to 1 of 2 treatment arms:
Arm I: Patients receive isolated limb perfusion (ILP) with tumor necrosis factor (TNF) and melphalan. After the limb is warmed, TNF is injected into the arterial line of the extracorporeal ILP circuit over 2-3 minutes beginning at time 0, and perfusion proceeds for another 25 minutes. Melphalan is injected into the same line over 3-5 minutes and perfusion with both drugs continues for another 60 minutes.
Arm II: Patients receive ILP with melphalan alone. Melphalan is injected into the arterial line of the extracorporeal ILP circuit over 3-5 minutes beginning approximately 30 minutes after initiation of perfusion as in arm I, and perfusion proceeds for 60 minutes.
Patients with potentially curable localized disease undergo a definitive local resection 4-12 weeks following ILP at the time of maximum tumor response as determined by physical exam and CT or MRI. Patients with microscopically positive viable tumor margins following resection receive adjuvant external beam radiotherapy as clinically indicated. If definitive local control cannot be confirmed with either local excision or biopsies, then amputation is recommended in the absence of unresectable metastatic disease. Local resection may also be performed on patients who achieve partial response. Patients with unresectable metastatic pulmonary disease who are undergoing ILP for palliative purposes do not undergo definitive resection.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 4 months thereafter in the absence of disease progression. Patients expected to undergo interval resection are followed every 4 weeks until the procedure is scheduled.
A total of 12-40 patients (6-20 per arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Randomized Study of Isolated Limb Perfusion Using Melphalan With or Without Tumor Necrosis Factor in Patients With Unresectable High Grade Soft Tissue Sarcomas of the Extremity|
|Study Start Date :||August 1999|
|Actual Study Completion Date :||March 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019968
|Study Chair:||H. Richard Alexander, Jr.||National Cancer Institute (NCI)|