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Sponsors and Collaborators: |
Maxim Pharmaceuticals National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00039234 |
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.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) Metastatic Cancer |
Biological: aldesleukin Drug: histamine dihydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV melanoma
At least 1 measurable lesion outside previously irradiated field
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No chronic systemic glucocorticoid steroids
Radiotherapy:
Surgery:
Other:
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 | |
Beth Israel Medical Center | |
New York, New York, United States, 10003 | |
Comprehensive Cancer Center at Our Lady of Mercy Medical Center | |
Bronx, New York, United States, 10466 | |
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 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Quebec | |
Centre Hospitalier Universitaire de Quebec | |
Quebec City, Quebec, Canada, G1R 2J6 | |
Germany | |
Charite - Universitaetsmedizin Berlin | |
Berlin, Germany, D-12200 | |
Kiel Universitatshautklinik | |
Kiel, Germany, DOH-24105 | |
Klinikum Rechts Der Isar/Technische Universitaet Muenchen | |
Munich, Germany, D-81675 | |
Klinische Kooperationseinheit fur Dermatoonkologie (DFKZ) | |
Mannheim, Germany, 68135 | |
Universitatsklinik - Saarland | |
Homburg/Saar, Germany, D-66421 | |
United Kingdom, England | |
Royal Marsden Hospital - Sutton | |
London, England, United Kingdom, SW3 6JJ |
Study Chair: | John A. Glaspy, MD, MPH | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069365, MAXIM-MP-8899-0104, UCLA-0111056, NCI-G02-2070, MSKCC-03057 |
Study First Received: | June 6, 2002 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00039234 History of Changes |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma liver metastases |
Neurotransmitter Agents Anti-HIV Agents Antiviral Agents Recurrence Melanoma Neuroendocrine Tumors Histamine Neuroectodermal Tumors Aldesleukin Anti-Retroviral Agents |
Analgesics, Non-Narcotic Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neoplasm Metastasis Neuroepithelioma Histamine phosphate Peripheral Nervous System Agents Analgesics Nevus |
Anti-Infective Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Neoplastic Processes Pathologic Processes Anti-Retroviral Agents Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Neoplasm Metastasis Nevi and Melanomas |
Analgesics Anti-HIV Agents Neoplasms by Histologic Type Histamine Agents Antiviral Agents Pharmacologic Actions Histamine Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Histamine Agonists Interleukin-2 Analgesics, Non-Narcotic Histamine phosphate |