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
- 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
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
Allocation: Randomized, Primary Purpose: Treatment
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Beth Israel Medical Center||New York, New York 10003|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Ellis Fischel Cancer Center at University of Missouri - Columbia||Columbia, Missouri 65203|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|James Graham Brown Cancer Center at University of Louisville||Louisville, Kentucky 40202|
|John Wayne Cancer Institute at Saint John's Health Center||Santa Monica, California 90404|
|Comprehensive Cancer Center at Our Lady of Mercy Medical Center||Bronx, New York 10466|
|Moffitt Clinic at Tampa General Hospital||Tampa, Florida 33612-9497|
|Melanoma Center of St. Louis, Missouri Baptist Medical Center||Saint Louis, Missouri 63131|