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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT00295958
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of metastatic melanoma
* Unresectable disease
* Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine)
* HLA-A0201 positive
* Measurable disease
* The following are not allowed:
* Resectable local/regional disease
* Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (\> 75% of the activity of 1 ug/mL of LMB-2)
* Received LMB-2 on another trial
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy more than 3 months
* WBC ≥ 3,000/mm\^3
* Absolute lymphocyte count \> 500/mm\^3
* Platelet count ≥ 90,000/mm\^3
* Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with Gilbert's syndrome)
* AST and ALT ≤ 2.5 times normal
* Albumin ≥ 3.0 g/dL
* No hepatitis B surface antigen or hepatitis C positivity
* Creatinine ≤ 1.4 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No ongoing or active infection
* Ejection fraction ≥ 45% by echocardiogram or thallium stress test (for patients \> 50 years of age OR who have a history of cardiovascular disease)
* LVEF ≥ 45%
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No known HIV positivity
* No autoimmune disease
* No immunodeficiency
* No other malignancies
* Must be willing to undergo leukapheresis
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 12 weeks since prior monoclonal antibody therapy
* More than 3 weeks since prior and no concurrent systemic therapy for cancer
* No concurrent chronic anticoagulant therapy
* No concurrent systemic steroid therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00295958
Study Brief:
Protocol Section:
NCT00295958