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:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT00324727
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed liver metastases secondary to cutaneous or ocular melanoma
* Unresectable disease
* Predominantly in the parenchyma of the liver
* Measurable disease by CT scan and/or MRI
* Limited unresectable extrahepatic disease allowed provided the life-limiting component of progressive disease is in the liver, including, but not limited to, any of the following:
* Up to 4 pulmonary nodules, each \< 1 cm in diameter
* Retroperitoneal lymph nodes \< 3 cm in diameter
* Less than 10 skin or subcutaneous metastases \< 1 cm in diameter
* Asymptomatic bone metastases that are eligible for or have undergone palliative external-beam radiotherapy
* Solitary metastasis to any site that can be resected
PATIENT CHARACTERISTICS:
* Life expectancy ≥ 3 months
* ECOG performance status 0-2
* Bilirubin \< 3.0 mg/dL
* PT within 2 seconds of upper limit of normal (ULN)
* AST/ALT ≤ 10 times ULN
* Platelet count \> 75,000/mm\^3
* Hematocrit \> 27% (may be achieved with a transfusion)
* Absolute neutrophil count ≥ 1,300/mm\^3
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min
* Fertile patients must use effective contraception
* Not pregnant or nursing
* Negative pregnancy test
* No history of congestive heart failure
* LVEF ≥ 40%
* No significant chronic obstructive pulmonary disease (COPD) or other chronic pulmonary restrictive disease
* FEV\_1 ≥ 30%
* DLCO ≥ 40% of predicted
* Weight ≥ 35 kg
* No untreated active bacterial infection with systemic manifestations (e.g., malaise, fever, and leucocytosis)
* No severe allergic reactions to iodine contrast unless reaction can be controlled by antihistamines and/or steroids
* No known hypersensitivity to melphalan
* No positive serology for HIV, hepatitis B surface antigen, or hepatitis C antibody (pharmacokinetics portion of the study only)
* No known latex allergy
* No Childs B or C cirrhosis
* No evidence of portal hypertension by history, endoscopy, or radiological study
* No prior history of gastrinoma
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 1 month since prior chemotherapy, radiotherapy, or biologic therapy for this cancer and recovered
* No prior regionally delivered melphalan
* No prior Whipple procedure
* No concurrent immunosuppressive therapy
* No concurrent chronic anticoagulation therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00324727
Study Brief:
Protocol Section:
NCT00324727