Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
NCT ID: NCT00003647
Last Updated: 2008-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1998-07-31
2002-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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allovectin-7
allovectin-7/dacarbazine
dacarbazine
Eligibility Criteria
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Inclusion 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
18 Years
No
Sponsors
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Vical
INDUSTRY
Principal Investigators
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Cherie Smith
Role: STUDY_CHAIR
Vical
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
Encinitas, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Georgia Cancer Specialists
Decatur, Georgia, United States
Georgia Cancer Specialists, P.C.
East Point, Georgia, United States
St. Francis Medical Center
Honolulu, Hawaii, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Lutheran General Hospital
Park Ridge, Illinois, United States
Cancer Care Center for Southern Indiana
Bloomington, Indiana, United States
Cancer Care Center
New Albany, Indiana, United States
Oncology and Hematology Associates
Westwood, Kansas, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
Louisiana State University School of Medicine
New Orleans, Louisiana, United States
Franklin Square Hospital Center
Baltimore, Maryland, United States
Providence Hospital Cancer Center
Southfield, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
North Memorial Health Care
Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Billings Interhospital Oncology Project
Billings, Montana, United States
Bergan Mercy Medical Center
Omaha, Nebraska, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
HemOnCare, P.C.
Brooklyn, New York, United States
Arena Oncology Associates
Great Neck, New York, United States
Beth Israel Medical Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States
Toledo Clinic, Inc.
Toledo, Ohio, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Danville Hematology and Oncology, Inc.
Danville, Virginia, United States
Cancer Treatment Centers of America in Hampton Roads
Portsmouth, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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VCL-1005-301
Identifier Type: -
Identifier Source: secondary_id
CDR0000066736
Identifier Type: -
Identifier Source: org_study_id
NCT00416416
Identifier Type: -
Identifier Source: nct_alias