A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
NCT ID: NCT00395070
Last Updated: 2013-09-13
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
390 participants
INTERVENTIONAL
2006-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Arm
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Allovectin-7®
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Control Arm
DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
Dacarbazine (DTIC)
1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
Temozolomide (TMZ)
150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
Interventions
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Allovectin-7®
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Dacarbazine (DTIC)
1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
Temozolomide (TMZ)
150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
Eligibility Criteria
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Inclusion Criteria
* At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected
* Normal blood chemistries and blood cell counts
* At least 18 years old and able and willing to provide informed consent to participate
Exclusion Criteria
* Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)
* If surgical removal of all lesions would be possible and could be curative
* Any melanoma tumors greater than 10cm x 10cm in size
* Known condition resulting in a suppressed immune system
* Female subjects who are pregnant
18 Years
ALL
No
Sponsors
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Vical
INDUSTRY
Responsible Party
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Principal Investigators
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Linda Strause, PhD
Role: STUDY_DIRECTOR
Vical
Locations
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Location #40
Tucson, Arizona, United States
Location #9
Little Rock, Arkansas, United States
Location #1
Bakersfield, California, United States
Location #24
San Diego, California, United States
Location #36
San Diego, California, United States
Location #47
San Francisco, California, United States
Location #16
Denver, Colorado, United States
Location #11
Lakeland, Florida, United States
Location #7
Chicago, Illinois, United States
Location #33
Chicago, Illinois, United States
Location #20
Louisville, Kentucky, United States
Location #35
Baltimore, Maryland, United States
Location #4
Kansas City, Missouri, United States
Location #19
St Louis, Missouri, United States
Location #38
Hackensack, New Jersey, United States
Location #8
Montclair, New Jersey, United States
Location #87
Albuquerque, New Mexico, United States
Location #41
Cincinnati, Ohio, United States
Location #23
Cleveland, Ohio, United States
Location #34
Portland, Oregon, United States
Location #12
Bethlehem, Pennsylvania, United States
Location #97
Providence, Rhode Island, United States
Location #28
Dallas, Texas, United States
Location #117
Houston, Texas, United States
Location #27
Salt Lake City, Utah, United States
Location #26
Salt Lake City, Utah, United States
Location #32
Seattle, Washington, United States
Location #55
Brussels, , Belgium
Location #63
Liège, , Belgium
Location #102
Itaquera, São Paulo, Brazil
Location #99
Belo Horizonte, , Brazil
Location #101
Curitiba, , Brazil
Location #104
Ijuí, , Brazil
Location #100
Lajeado, , Brazil
Location #103
Porto Alegre, , Brazil
Location #105
Rio de Janeiro, , Brazil
Location #106
São Paulo, , Brazil
Location #37
Calgary, Alberta, Canada
Location #88
Winnipeg, Manitoba, Canada
Location # 75
Ottawa, Ontario, Canada
Location #110
Bordeaux, , France
Location #112
Lyon, , France
Location #113
Marseille, , France
Location #114
Montpellier, , France
Location #109
Nantes, , France
Location #66
Paris, , France
Location #74
Paris, , France
Location #115
Toulouse, , France
Location #116
Villejuif, , France
Location #90
Augsburg, , Germany
Location #51
Berlin, , Germany
Location #91
Dresden, , Germany
Location #46
Hanover, , Germany
Location #89
Jena, , Germany
Location #50
Kiel, , Germany
Location #111
Ludwigshafen, , Germany
Location #48
Lübeck, , Germany
Location #44
Münster, , Germany
Location #52
Tübingen, , Germany
Location #45
Würzburg, , Germany
Location #86
Jerusalem, , Israel
Location #84
Petah Tikva, , Israel
Location #85
Tel Litwinsky, , Israel
Location #82
Genoa, , Italy
Location #78
Milan, , Italy
Location #79
Napoli, , Italy
Location #80
Padua, , Italy
Location #81
Siena, , Italy
Location #59
Groningen, , Netherlands
Location #60
Leiden, , Netherlands
Location #72
Lubin, , Poland
Location #65
Poznan, , Poland
Location #93
Barnaul, , Russia
Location #61
Moscow, , Russia
Location #58
Moscow, , Russia
Location #62
Nizniy Novogrod, , Russia
Location #57
Saint Petersburg, , Russia
Location #94
Samara, , Russia
Location #95
Stavropol, , Russia
Location #67
Barcelona, , Spain
Location #54
Valencia, , Spain
Location #68
Zaragoza, , Spain
Location #118
Bern, , Switzerland
Location #43
Zurich, , Switzerland
Location #122
Ankara, , Turkey (Türkiye)
Location #124
Antalya, , Turkey (Türkiye)
Location #121
Izmir, , Turkey (Türkiye)
Location #123
Kocaeli, , Turkey (Türkiye)
Countries
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Other Identifiers
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LX01-315
Identifier Type: -
Identifier Source: org_study_id