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Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma Clinical research trials and Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), 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-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma  Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Suspended
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 and interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma.
Details: OBJECTIVES: - Determine the clinical response rate in patients with metastatic malignant melanoma treated with interleukin-12 and interferon alfa. - Determine the progression-free survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive interleukin-12 IV over 5-15 seconds on day 1 and interferon alfa subcutaneously on days 2-6. Treatment repeats every 2 weeks in the absence of unacceptable toxicity. Patients are reassessed after 6 courses. Patients with a complete response receive 2 additional courses. Patients with a partial response or stable disease continue treatment in the absence of disease progression. Patients are followed every 3 months for 1 year and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 6-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed cutaneous melanoma - Clinically evident distant, metastatic, unresectable regional lymphatic, or extensive in transit recurrent disease - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - The following are not considered measurable: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses not confirmed and followed by imaging techniques - Lytic lesions - Lesions in a previously irradiated area - No brain metastases or other CNS disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin greater than 9 g/dL (transfusion or epoetin alfa allowed) - No hemolytic anemia Hepatic: - Hepatitis B surface antigen negative Renal: - Not specified Cardiovascular: - No uncontrolled or severe cardiovascular disease Pulmonary: - No pulmonary disease Other: - HIV negative - No prior peripheral neuropathy - No active or unresolved severe peptic ulcer disease or gastrointestinal bleeding - No history of or active autoimmune disease - No concurrent infection - No diabetes - No other major active illness - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior interleukin-12 - No prior interferon alfa for metastatic disease - Prior adjuvant interferon alfa allowed provided patient is disease-free for at least 12 months after last treatment - No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-12) Chemotherapy: - At least 3 weeks since prior chemotherapy - No more than 1 prior chemotherapy regimen Endocrine therapy: - At least 3 weeks since prior anti-hormonal therapy Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamCarson, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
Walt Disney Memorial Cancer Institute at Florida Hospital
Orlando, Florida, 32804
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068990; CLB-500001
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026143
Other Recurrent Melanoma Studies:
1. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
2. CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma
3. Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
4. Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
5. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other North Carolina Clinical Trials
Other Kinston Clinical Trials
Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
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