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Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma Clinical research trials and Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma. Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma clinical trial. Subjects often receive the most expert healthcare possible for their Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma  Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
For Condition: stage 3 melanoma,Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): Vical ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.
Details: OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone. II. Determine the benefits, risks, and side effects of these regimens in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms. Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10. Patients with stable or responding disease may receive additional courses every 28 days. Patients are followed every 4 months. PROJECTED ACCRUAL: A total of 280 patients (140 in each arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option - Dacarbazine is indicated as first line chemotherapy - At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2 - No history of brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy - Chemotherapy: See Disease Characteristics; No prior chemotherapy - Endocrine therapy: No concurrent immunosuppressive drugs - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: At least 2 weeks since prior major surgery - Other: No other concurrent anticancer drug therapy or experimental therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 80-100% - Life expectancy: At least 24 weeks - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease - Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CherieSmith, Study Chair, Vical
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43222
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
North Memorial Health Care
Robbinsdale, Minnesota, 55422
United States
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
United States
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Mid Dakota Clinic, P.C.
Bismark, North Dakota, 58501
United States
Oncology and Hematology Associates
Westwood, Kansas, 66205
United States
Beth Israel Medical Center
New York City, New York, 10003
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Cancer Treatment Centers of America in Hampton Roads
Portsmouth, Virginia, 23704
United States
Arena Oncology Associates
Great Neck, New York, 11021
United States
Cancer Care Center
New Albany, Indiana, 47150
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541
United States
Cancer Care Center for Southern Indiana
Bloomington, Indiana, 47403
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Toledo Clinic, Inc.
Toledo, Ohio, 43623
United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Providence Hospital Cancer Center
Southfield, Michigan, 48075
United States
Park Nicollet Clinic
St. Louis Park, Minnesota, 55416
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Bergan Mercy Medical Center
Omaha, Nebraska, 68124
United States
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
Encinitas, California, 92023
United States
Billings Interhospital Oncology Project
Billings, Montana, 59101
United States
St. Francis Medical Center
Honolulu, Hawaii, 96817
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
Lutheran General Hospital
Park Ridge, Illinois, 60068
United States
Georgia Cancer Specialists
Decatur, Georgia, 30033
United States
Georgia Cancer Specialists, P.C.
East Point, Georgia, 30344
United States
Additional Information:
Study ID Numbers: CDR0000066736; VCL-1005-301
Study Start Date: October 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003647
Other Stage 4 Melanoma Studies:
1. Biological Therapy in Treating Patients With Metastatic Melanoma
2. Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
3. Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
4. Boron Neutron Capture Therapy in Treating Patients With Melanoma
5. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Kentucky Clinical Trials
Other Lexington Clinical Trials
Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
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