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

NCT00039234 | Unknown Phase 3

• 5 other identifiers: CDR0000069365MAXIM-MP-8899-0104UCLA-0111056NCI-G02-2070MSKCC-03057
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 19

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the liver. PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver.

Conditions

Melanoma (Skin); Metastatic Cancer

Keywords

stage IV melanoma; recurrent melanoma; liver metastases

Interventions

aldesleukin BIOLOGICAL

histamine dihydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maxim Pharmaceuticals: lead
• National Cancer Institute (NCI): collaborator

Study Sites (19)

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, 90404, United States

Location

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

Aurora, Colorado, 80010, United States

Location

Moffitt Clinic at Tampa General Hospital

Tampa, Florida, 33612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Melanoma Center of St. Louis, Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Comprehensive Cancer Center at Our Lady of Mercy Medical Center

The Bronx, New York, 10466, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Charite - Universitaetsmedizin Berlin

Berlin, D-12200, Germany

Location

Universitatsklinik - Saarland

Homburg/Saar, D-66421, Germany

Location

Kiel Universitatshautklinik

Kiel, DOH-24105, Germany

Location

Klinische Kooperationseinheit fur Dermatoonkologie (DFKZ)

Mannheim, 68135, Germany

Location

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Royal Marsden Hospital - Sutton

London, England, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

aldesleukin; Histamine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• John A. Glaspy, MD, MPH

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Last Updated: December 18, 2013

Record last verified: 2003-12

Locations

US (11); CA (2); GB (1); DE (5)