Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00565968
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary or recurrent extremity melanoma
* Stage IIIB or IIIC disease
* Patients with stage IIIC disease must have had regional lymph nodes previously removed
* Disease to be treated by regional therapy must be distal to the planned site of tourniquet placement
* Bidimensionally measurable disease by caliper or radiological method
* Must have identifiable target lesions for disease assessment
* Patients with a single lesion must have archived tumor tissue available for research analysis
* No stage IV disease
* No known brain metastasis
* Patients with neurological symptoms must have undergone a CT scan or MRI of the brain within the past 4 weeks to exclude brain metastasis
PATIENT CHARACTERISTICS:
* ECOG or Zubrod performance status 0-1
* Life expectancy \> 6 months
* Hemoglobin ≥ 9.0 g/dL
* WBC ≥ 3,000/mm\^3
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* ALT and AST ≤ 2.5 x ULN
* INR \< 1.5 or PT/PTT normal
* Creatinine ≤ 1.5 x ULN
* Not pregnant or nursing
* Negative serum pregnancy test
* Fertile patients must use effective contraception
* Must have a palpable femoral or axillary pulse in the extremity to be treated
* No cardiac disease, including any of the following:
* NYHA class III or IV congestive heart failure
* Unstable angina (i.e., angina symptoms at rest) or new onset angina within the past 3 months
* Myocardial infarction within the past 6 months
* No cardiac ventricular arrhythmias requiring antiarrhythmic therapy
* No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management
* No known HIV infection
* No chronic hepatitis B or C
* No active clinically serious infection \> CTCAE grade 2
* No thrombotic or embolic events (e.g., cerebrovascular accident or transient ischemic attacks) within the past 6 months
* No signs or symptoms of vascular insufficiency (i.e., any history of blood clots or other ischemic peripheral vascular disease)
* No evidence or history of bleeding diathesis or coagulopathy
* No pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks
* No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
* No serious nonhealing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 4 weeks
* No condition that impairs the patient's ability to swallow whole pills
* No malabsorption problem
* No known history of allergic reactions and/or hypersensitivity to melphalan, sorafenib tosylate, or any other agent used in the study
* No psychiatric condition or diminished capacity that would compromise giving informed consent, or interfere with study compliance
* No history of other malignancies, except for any of the following:
* Adequately treated basal cell or squamous cell carcinoma of the skin
* Curatively treated in situ carcinoma of the uterine cervix, prostate cancer, or superficial bladder cancer
* Other curatively treated solid tumor with no evidence of disease for ≥ 5 years
PRIOR CONCURRENT THERAPY:
* Recovered from prior therapy
* No prior sorafenib tosylate
* Prior melphalan via isolated limb infusion allowed
* No antineoplastic therapy, radiotherapy, or any other investigational drug within the past 4 weeks
* No major surgery or open biopsy within the past 4 weeks
* No concurrent Hypericum perforatum (St. John wort) or rifampin
* Concurrent anti-coagulation treatment with warfarin or heparin allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00565968
Study Brief:
Protocol Section:
NCT00565968