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Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver Clinical research trials and Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver clinical trial. Participants frequently obtain the most expert healthcare available for their Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver  Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
For Condition: Stage 4 Melanoma,Recurrent Melanoma,liver metastases
Status: No longer recruiting
Sponsor(s): Maxim Pharmaceuticals , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGlaspy, Study Chair, Jonsson Comprehensive Cancer Center
Universitatsklinik - Saarland
HOMBURG / SAAR, , D-66421
Germany
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
Bronx, New York, 10466
United States
Royal Marsden Hospital - Sutton
London, England, SW3 6JJ
United Kingdom
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Beth Israel Medical Center
New York City, New York, 10003
United States
Moffitt Clinic at Tampa General Hospital
Tampa, Florida, 33612
United States
Charite - Universitaetsmedizin Berlin
Berlin, , D-12200
Germany
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, , D-81675
Germany
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Klinische Kooperationseinheit fur Dermatoonkologie (DFKZ)
Mannheim, , 68135
Germany
Melanoma Center of St. Louis, Missouri Baptist Medical Center
St. Louis, Missouri, 63131
United States
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, 90404
United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Kiel Universitatshautklinik
Kiel, , DOH-24105
Germany
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
United States
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
United States
Additional Information:
Study ID Numbers: CDR0000069365; MSKCC-03057,NCI-G02-2070,MAXIM-MP-8899-0104,UCLA-0111056
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039234
Other Recurrent Melanoma Studies:
1. Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
2. CCI-779 in Treating Patients With Metastatic Melanoma
3. Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
4. BMS-247550 in Treating Patients With Stage IV Melanoma
5. E7070 in Treating Patients With Stage IV Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
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