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Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma Clinical research trials and Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma clinical trial. Subjects typically recieve the finest healthcare available for their Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma  Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Suspended
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma.
Details: OBJECTIVES: - Determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2. - Assess response duration and progression-free intervals in these patients receiving this treatment. OUTLINE: Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 3 additional courses after achieving CR. Patients are followed every 9 weeks for 3 years or until disease recurrence. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed cutaneous melanoma with clinical evidence of distant, metastatic, unresectable regional lymphatic, or extensive in-transit recurrent disease - HLA-A2*0201 positive by genotyping - Measurable disease as defined by the following: - At least 1 lesion accurately measured in at least 1 dimension - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Lesions considered intrinsically nonmeasurable include: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - Lesions situated in a previously irradiated area - No ocular or mucosal melanoma - No prior or concurrent liver or brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Platelet count at least 100,000/mm3 - Hemoglobin at least 10 g/dL Hepatic: - LDH normal - Bilirubin normal - AST no greater than 2.5 times upper limit of normal Renal: - Creatinine normal Cardiovascular: - No congestive heart failure, angina, or symptomatic cardiac arrhythmia - No myocardial infarction within the past 6 months Pulmonary: - No severe chronic pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No primary or secondary immunodeficiency or autoimmune disease - No currently active second malignancy (e.g., patient has completed therapy and is considered unlikely to have recurrence within 1 year) other than nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No prior interleukin-2 - No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine - No other concurrent cytokines or growth factors Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - At least 1 month since prior systemic corticosteroids - No concurrent systemic, inhaled, or topical corticosteroids Radiotherapy: - See Disease Characteristics Surgery: - Not specified Other: - At least 1 month since other prior immunosuppressive medication - No antihypertensive medications from 1 day prior until 2 days after first course
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnRoberts, Study Chair, Massey Cancer Center
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
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Massey Cancer Center
Richmond, Virginia, 23219
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067886; CLB-509901
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005949
Other Stage 4 Melanoma Studies:
1. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
2. Vaccine Therapy in Treating Patients With Stage IV Melanoma
3. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
4. Vaccine Therapy in Treating Patients With Metastatic Melanoma
5. Cilengitide in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
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