Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
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.
Drug: histamine dihydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Phase III, Multi-Center Controlled Trial With Stratified Randomization Comparing The Efficacy Of Interleukin-2 (IL-2) Plus Histamine Dihydrochloride (HDC) Versus IL-2 Alone To Increase The Duration Of Survival In Patients With AJCC Stage IV Malignant Melanoma With Hepatic Metastasis|
|Study Start Date:||September 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039234
|United States, California|
|John Wayne Cancer Institute at Saint John's Health Center|
|Santa Monica, California, United States, 90404|
|United States, Colorado|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center|
|Aurora, Colorado, United States, 80010|
|United States, Florida|
|Moffitt Clinic at Tampa General Hospital|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Kentucky|
|James Graham Brown Cancer Center at University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Missouri|
|Ellis Fischel Cancer Center at University of Missouri - Columbia|
|Columbia, Missouri, United States, 65203|
|Melanoma Center of St. Louis, Missouri Baptist Medical Center|
|Saint Louis, Missouri, United States, 63131|
|United States, New York|
|Comprehensive Cancer Center at Our Lady of Mercy Medical Center|
|Bronx, New York, United States, 10466|
|Beth Israel Medical Center|
|New York, New York, United States, 10003|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Centre Hospitalier Universitaire de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Charite - Universitaetsmedizin Berlin|
|Berlin, Germany, D-12200|
|Universitatsklinik - Saarland|
|Homburg/Saar, Germany, D-66421|
|Kiel, Germany, DOH-24105|
|Klinische Kooperationseinheit fur Dermatoonkologie (DFKZ)|
|Mannheim, Germany, 68135|
|Klinikum Rechts Der Isar/Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Royal Marsden Hospital - Sutton|
|London, England, United Kingdom, SW3 6JJ|
|Study Chair:||John A. Glaspy, MD, MPH||Jonsson Comprehensive Cancer Center|