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Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg Clinical research trials and Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg. Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg clinical trial. Participants frequently get the best healthcare available for their Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg  Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg
Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg
For Condition: stage 3 melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): American College of Surgeons , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Randomizedphase III trial to compare the effectiveness of hyperthermicisolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have locally advanced melanoma of the arm or leg.
Details: OBJECTIVES: - 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. - Compare the local recurrence-free survival, improvement in regional symptoms related to tumor, and overall survival in patients treated with these regimens. - 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 infraclavicular/axillary 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. PROJECTED ACCRUAL: A total of 216 patients (108 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven locally advanced melanoma of an extremity - One or more evaluable in-transit metastases OR - All disease within the perfusion field of the extremity (with no local resection options short of amputation) OR - Disease outside of perfusion field (with no local resection options short of amputation) if all the following are true: - High tumor burden (more than 10 lesions or any single lesion greater than 3 cm) - Presence of pain, edema, skin breakdown, or decreased mobility - Greater than 80% of known tumor is within extremity perfusion field - Life expectancy more than 6 months - No brain metastases - At least 1 bidimensionally measurable lesion - Patients who received prior prophylactic isolated limb perfusion (ILP) must have 1 of the following: - Disease-free interval for at least 6 months after prior ILP with melphalan - Disease-free interval for at least 3 months after prior ILP with an agent other than melphalan - Patients who received prior therapeutic ILP must have 1 of the following: - Partial response of at least 3 months duration after prior ILP with melphalan - Stable response or disease progression after ILP without melphalan (performed at least 3 months prior to study) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - See Disease Characteristics Hematopoietic: - Platelet count at least 100,000/mm^3 - WBC greater than 2,500/mm^3 - Hemoglobin greater than 9 g/dL Hepatic: - Bilirubin less than 1.25 times ULN - AST and ALT less than 2 times ULN - Alkaline phosphatase less than 2 times ULN - Coagulation studies normal or within 1 second of upper limit of normal (ULN) Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 50 mL/min - Calcium less than 12 mg/dL Cardiovascular: - No severe peripheral vascular disease (claudication or other ischemic peripheral vascular disease [e.g., venous thrombosis or occlusive peripheral arterial disease]) - No New York Heart Association class II-IV heart disease (congestive heart failure) - No uncontrolled or life-threatening cardiac arrhythmia - No myocardial infarction within the past year - No unstable angina - No symptomatic cerebral or carotid artery disease Pulmonary: - No pulmonary embolism within the past year Other: - Other prior malignancy allowed if completed curative therapy, disease-free for at least 5 years, and at low risk for recurrence - No active peptic ulcer disease within the past year - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known melphalan hypersensitivity - No known hypersensitivity to any component of tumor necrosis factor alpha formulation - No contraindications to ionotropic agents (e.g., dopamine or neosynephrine) - No concurrent infections uncontrolled with antibiotics - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 month since prior biologic therapy Chemotherapy: - See Disease Characteristics - At least 1 month since prior chemotherapy - At least 4 months since prior isolated limb perfusion Endocrine therapy: - Not specified Radiotherapy: - At least 1 month since prior radiotherapy Surgery: - See Disease Characteristics - At least 12 months since prior coronary artery surgery or angioplasty
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DouglasFraker, Study Chair, University of Pennsylvania Cancer Center
University of Illinois Medical Center
Chicago, Illinois, 60612
United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45219
United States
Additional Information:
Study ID Numbers: CDR0000066929; ACOSOG-Z0020,NCI-03-C-0137
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003789
Other Recurrent Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
2. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
3. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
4. Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
5. Interferon gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Illinois Clinical Trials
Other Evanston Clinical Trials
Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg
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