Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
Melanoma (Skin), Metastatic Cancer
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma, liver metastases
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
Sites / Locations
- John Wayne Cancer Institute at Saint John's Health Center
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Moffitt Clinic at Tampa General Hospital
- University of Chicago Cancer Research Center
- James Graham Brown Cancer Center at University of Louisville
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Melanoma Center of St. Louis, Missouri Baptist Medical Center
- Comprehensive Cancer Center at Our Lady of Mercy Medical Center
- Beth Israel Medical Center
- Memorial Sloan-Kettering Cancer Center
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
- Cross Cancer Institute
- Centre Hospitalier Universitaire de Quebec
- Charite - Universitaetsmedizin Berlin
- Universitatsklinik - Saarland
- Kiel Universitatshautklinik
- Klinische Kooperationseinheit fur Dermatoonkologie (DFKZ)
- Klinikum Rechts Der Isar/Technische Universitaet Muenchen
- Royal Marsden Hospital - Sutton