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Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (19)

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, 90404, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Moffitt Clinic at Tampa General Hospital

Tampa, Florida, 33612, United States

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

MeSH Terms

Conditions

MelanomaNeoplasm Metastasis

Interventions

aldesleukinHistamine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin Diseases

Source record

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Source: ClinicalTrials.gov.

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Registry identifier

NCT00039234

Data provider

ClinicalTrials.gov

Source updated

2013-12-18

Normalization version

ctgov-legacy-1

Source retrieved: 2026-10-25 22:24:23 UTC

Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

Brief Summary

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Study Sites (19)

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Brief Summary

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Study Sites (19)

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