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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT00505635
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible.
2. They should have recurrent melanoma with measureable or evaluable sites of disease in order to assess the response to treatment by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
3. Patients between 18 years of age and 65 years of age with an expected survival greater than 8 weeks and a Karnofsky performance status of 50% or better or an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 will be eligible.
4. They should have normal blood counts with a white blood count (WBC) count of more than or equal to 3000/mm\^3 an absolute neutrophil count of more than or equal to 1500/mm\^3 and a platelet count of more than 100,000/mm\^3 and have no impairment of renal function (serum creatinine of less than 1.6 mg/dl), hepatic function (serum bilirubin level of \< 1.2 mg/dl) and no evidence of significant cardiac or pulmonary dysfunction.
5. They should have no significant intercurrent illness such as an active infection, uncontrolled psychiatric illness, hypercalcemia (calcium \> 11 mg), or active GI bleeding.
6. They should not have been exposed to any previous chemotherapy or isolation perfusion for malignant melanoma and have had no previous exposure to interleukin-2. Prior adjuvant interferon is permitted. Prior radiation therapy for metastatic melanoma is permitted provided the patient has un-irradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
Exclusion Criteria:
1. Patients with brain and/or bone metastases only.
2. Patients with symptomatic central nervous system involvement by melanoma either as brain metastasis by MRI or spinal cord compression. Patients with brain metastases are not eligible unless their disease can be resected, it is asymptomatic, not associated with cerebral edema, or they are clinically stable after radiation and off corticosteroid therapy for 4 weeks. No major surgery or RT within 21 days before starting of treatment.
3. Patients with significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricle function (EF \<55%) on account of any organic disease such as hypertension or valvular heart disease or serious cardiac arrhythmia requiring therapy. Patients with an electrocardiogram (EKG) disclosing an absolute QT interval \>460 msec in the presence of serum potassium \>/=4.0 mEq/L and magnesium \>/= 1.8 mg/dL. Patients with heart rate less than 50.
4. Patients with significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD) which has resulted in impairment of vital capacity of Left Ventricular Ejection Fraction (FE VI) to \<75% of predicted normal values.
5. Patients with symptomatic effusions on account of pleural, pericardial or peritoneal metastases of melanoma.
6. Patients who are unable to stay in Houston to receive therapy (first cycle) and be able to return for follow-up visits as required by this study.
7. Patients with a history of second malignant tumor, other than the common skin cancers - basal and squamous carcinomas, within the past 5 years and uncertainty about the histological nature of the metastatic lesions.
8. Patients with history of deep vein thrombi (DVT) or pulmonary embolism (PE) are excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00505635
Study Brief:
Protocol Section:
NCT00505635