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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00039234
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV melanoma
* Must have radiological evidence of lesions in liver (target or non-target)
* At least 1 measurable lesion outside previously irradiated field
* At least 20 mm by contrast-enhanced CT scan, MRI, medical photography, or physical exam OR at least 10 mm by spiral CT scan
* No prior or concurrent clinical and/or objective evidence of brain metastasis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-1
Life expectancy:
* At least 3 months
Hematopoietic:
* Hemoglobin at least 9.5 g/dL
* WBC at least 3,000/mm\^3
* Granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST and ALT no greater than 4 times ULN
* Alkaline phosphatase no greater than 4 times ULN
* Hepatitis B and C negative
Renal:
* Creatinine no greater than 1.7 mg/dL
* Calcium no greater than 11.5 mg/dL
Cardiovascular:
* No abnormal thallium stress test
* No acute myocardial infarction within the past year
* No New York Heart Association class III or IV heart disease
Pulmonary:
* No asthma requiring active treatment within the past 5 years
* Oxygen saturation by pulse oximeter at least 90% unless FEV\_1 is greater than 2 L or at least 75% predicted
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* Concurrent medically-controlled (except with glyburide) or diet-controlled diabetes is allowed
* Concurrent medically-controlled thyroid dysfunction is allowed
* No other active malignancy within the past 5 years except carcinoma in situ of the cervix or localized squamous cell or basal cell skin cancer
* No serious non-malignant medical conditions, including psychiatric disability, that would preclude study compliance
* No active autoimmune disease (e.g., lupus, inflammatory bowel disease, or psoriasis)
* No active peptic and/or esophageal ulcer disease
* No hypersensitivity to histamine products or urticaria
* No active IV drug abuse
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy with high-dose IV interleukin-2 (IL-2)
* No prior combination immunotherapy with chemotherapy
* At least 1 year since prior low-dose adjuvant IL-2 as part of vaccine therapy or as therapy for stage II or III melanoma
Chemotherapy:
* See Biologic therapy
Endocrine therapy:
* No chronic systemic glucocorticoid steroids
* Asthma inhalers, topical creams, or intra-articular injections allowed
* Hormonal therapy for non-melanoma-related conditions allowed
Radiotherapy:
* See Disease Characteristics
* Concurrent radiotherapy as palliative therapy for isolated non-target lesions (e.g., bone lesions) allowed
Surgery:
* Not specified
Other:
* At least 4 weeks since prior therapy directed at malignancy
* At least 4 weeks since prior investigational medications or therapies
* At least 2 weeks since prior parenteral antioxidants and/or vitamins
* At least 2 weeks since prior antibiotics for active illness
* At least 2 weeks since prior H2 antagonists, beta-blockers, antihypertensives, antimalarials, antitrypanosomals, neuromuscular-blocking agents, tricyclic antidepressants, or alprazolam
* At least 24 hours since prior antihistamines
* No prior enrollment in any Maxim Pharmaceuticals investigational trials
* No concurrent anticonvulsant therapy for seizure disorder
* No other concurrent investigational drug
* No concurrent H2 antagonists, tricyclic antidepressants, alprazolam, beta- blockers, antihypertensives, antitrypanosomals, antimalarials, or monoamine oxidase inhibitors
* No concurrent inhibitors of diamine oxidase, monoamine oxidase, or histamine N-methyltransferase
* No concurrent antihistamines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00039234
Study Brief:
Protocol Section:
NCT00039234