Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
- Conditions
- Melanoma (Skin)Metastatic Cancer
- Registration Number
- NCT00039234
- Lead Sponsor
- Maxim Pharmaceuticals
- 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.
- Detailed Description
OBJECTIVES:
* Compare the duration of survival in patients with stage IV melanoma with hepatic metastasis treated with interleukin-2 with or without histamine dihydrochloride.
* Compare the progression-free survival, response rate, response rate of hepatic tumors, and lack of disease progression in patients treated with these regimens.
* Determine the safety of these regimens, in terms of frequency, severity, and causal relationship of adverse events, in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center location (North America vs Europe), lactate dehydrogenase (less than ULN vs ULN or greater), and metastatic sites (liver only vs liver and other sites). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive interleukin-2 (IL-2) subcutaneously (SC) twice daily on days 1 and 2 of weeks 1 and 3 and days 1-5 of weeks 2 and 4. Patients also receive histamine dihydrochloride SC over 10-30 minutes on days 1-5 of weeks 1-4.
* Arm II: Patients receive IL-2 as in arm I. In both arms, treatment repeats every 6 weeks for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 224 patients (112 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Royal Marsden Hospital - Sutton
🇬🇧London, England, United Kingdom
John Wayne Cancer Institute at Saint John's Health Center
🇺🇸Santa Monica, California, United States
Moffitt Clinic at Tampa General Hospital
🇺🇸Tampa, Florida, United States
Kiel Universitatshautklinik
🇩🇪Kiel, Germany
Charite - Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Universitatsklinik - Saarland
🇩🇪Homburg/Saar, Germany
Klinische Kooperationseinheit fur Dermatoonkologie (DFKZ)
🇩🇪Mannheim, Germany
Melanoma Center of St. Louis, Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
🇺🇸Bronx, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
🇩🇪Munich, Germany
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada