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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00091104
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of metastatic melanoma
* HLA-A\*0201-positive disease
* Measurable disease
* Refractory to standard therapy, including high-dose aldesleukin therapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* More than 3 months
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 8.0 g/dL
* Lymphocyte count \> 500/mm\^3
* WBC \> 3,000/mm\^3
* No coagulation disorder
Hepatic
* ALT and AST \< 3 times upper limit of normal
* Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL for patients with Gilbert's disease)
* Hepatitis B antigen negative
* Hepatitis C antibody negative (unless antigen negative)
Renal
* Creatinine ≤ 1.6 mg/dL
Cardiovascular
* No myocardial infarction
* No cardiac arrhythmias
* No cardiac ischemia
* LVEF ≥ 45% by stress cardiac test\* (for patients ≥ 50 years of age OR those with a history of EKG abnormalities)
* No other major cardiovascular illness by stress thallium or comparable test NOTE: \*Stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test
Pulmonary
* No major respiratory illness
* No obstructive or restrictive pulmonary disease
* FEV\_1 ≥ 60% of predicted on pulmonary function test\*
* DLCO ≥ 60% predicted (for total-body irradiation cohort) NOTE: \*For patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction
Immunologic
* HIV negative
* No major immune system illness
* No active systemic infection or opportunistic infection
* No primary immunodeficiency (e.g., autoimmune colitis or Crohn's disease)
* No secondary immunodeficiency (e.g., due to chemotherapy or radiotherapy)
* No history of severe immediate hypersensitivity reaction to study drugs
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after completion of study treatment
* Must sign a durable power of attorney
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* Recovered from prior immunotherapy
* Prior immunization to melanoma antigens allowed
* Progressive disease during prior immunization allowed
* Prior cellular therapy, including vector transduction with or without myeloablation, allowed
* More than 6 weeks since prior anticytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) monoclonal antibody (MDX-010) therapy
* No prior anti-CTLA-4 antibody unless a post anti-CTLA-4 antibody treatment colonoscopy was normal by biopsy
Chemotherapy
* Recovered from prior chemotherapy
Endocrine therapy
* No concurrent systemic steroids
Radiotherapy
* Recovered from prior radiotherapy
* No prior significant mediastinal or lung radiation (for total-body irradiation cohort)
Surgery
* Not specified
Other
* More than 4 weeks since prior systemic therapy and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00091104
Study Brief:
Protocol Section:
NCT00091104