A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
- Conditions
- Metastatic Melanoma
- Interventions
- Registration Number
- NCT00395070
- Lead Sponsor
- Vical
- Brief Summary
To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.
- Detailed Description
Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Dacarbazine (DTIC) 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. Control Arm Temozolomide (TMZ) 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. Treatment Arm Allovectin-7® Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
- Primary Outcome Measures
Name Time Method To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm. After all 375 subjects are enrolled
- Secondary Outcome Measures
Name Time Method To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. After all 375 subjects are enrolled To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. After all 375 subjects are enrolled
Trial Locations
- Locations (88)
Location #23
🇺🇸Cleveland, Ohio, United States
Location #117
🇺🇸Houston, Texas, United States
Location #32
🇺🇸Seattle, Washington, United States
Location #58
🇷🇺Moscow, Russian Federation
Location #94
🇷🇺Samara, Russian Federation
Location #62
🇷🇺Nizniy Novogrod, Russian Federation
Location #40
🇺🇸Tucson, Arizona, United States
Location #38
🇺🇸Hackensack, New Jersey, United States
Location #118
🇨🇭Bern, Switzerland
Location #63
🇧🇪Liege, Belgium
Location #55
🇧🇪Brussels, Belgium
Location #46
🇩🇪Hannover, Germany
Location #79
🇮🇹Napoli, Italy
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 #7
🇺🇸Chicago, Illinois, United States
Location #16
🇺🇸Denver, Colorado, United States
Location #11
🇺🇸Lakeland, Florida, United States
Location #20
🇺🇸Louisville, Kentucky, United States
Location #33
🇺🇸Chicago, Illinois, United States
Location #35
🇺🇸Baltimore, Maryland, United States
Location #4
🇺🇸Kansas City, Missouri, United States
Location #19
🇺🇸St. Louis, Missouri, United States
Location #8
🇺🇸Montclair, New Jersey, United States
Location #41
🇺🇸Cincinnati, Ohio, United States
Location #87
🇺🇸Albuquerque, New Mexico, United States
Location #34
🇺🇸Portland, Oregon, United States
Location #12
🇺🇸Bethlehem, Pennsylvania, United States
Location #27
🇺🇸Salt Lake City, Utah, United States
Location #28
🇺🇸Dallas, Texas, United States
Location #26
🇺🇸Salt Lake City, Utah, United States
Location #102
🇧🇷Itaquera, Sao Paulo, Brazil
Location #99
🇧🇷Belo Horizonte, Brazil
Location #104
🇧🇷Ijui, Brazil
Location #101
🇧🇷Curitiba, Brazil
Location #100
🇧🇷Lajeado, Brazil
Location #103
🇧🇷Porto Alegre, Brazil
Location #105
🇧🇷Rio de Janeiro, Brazil
Location #106
🇧🇷Sao Paulo, Brazil
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 #74
🇫🇷Paris Cedex 10, France
Location #66
🇫🇷Paris Cedex 18, France
Location #115
🇫🇷Toulouse, France
Location #116
🇫🇷Villejuif, France
Location #90
🇩🇪Augsburg, Germany
Location #91
🇩🇪Dresden, Germany
Location #51
🇩🇪Berlin, Germany
Location #89
🇩🇪Jena, Germany
Location #50
🇩🇪Kiel, Germany
Location #48
🇩🇪Lubeck, Germany
Location #86
🇮🇱Jerusalem, Israel
Location #111
🇩🇪Ludwigshafen, Germany
Location #44
🇩🇪Munster, Germany
Location #52
🇩🇪Tubingen, Germany
Location #45
🇩🇪Wurzburg, Germany
Location #84
🇮🇱Petach Tikva, Israel
Location #85
🇮🇱Tel Hashomer, Israel
Location #82
🇮🇹Genoa, Italy
Location #78
🇮🇹Milan, Italy
Location #80
🇮🇹Padova, Italy
Location #81
🇮🇹Siena, Italy
Location #59
🇳🇱Groningen, Netherlands
Location #60
🇳🇱Leiden, Netherlands
Location #65
🇵🇱Poznan, Poland
Location #72
🇵🇱Lubin, Poland
Location #93
🇷🇺Barnaul, Russian Federation
Location #61
🇷🇺Moscow, Russian Federation
Location #88
🇨🇦Winnipeg, Manitoba, Canada
Location #57
🇷🇺St. Petersburg, Russian Federation
Location #95
🇷🇺Stavropol, Russian Federation
Location #67
🇪🇸Barcelona, Spain
Location #54
🇪🇸Valencia, Spain
Location #68
🇪🇸Zaragoza, Spain
Location #43
🇨🇭Zurich, Switzerland
Location #122
🇹🇷Ankara, Turkey
Location #124
🇹🇷Antalya, Turkey
Location #121
🇹🇷Izmir, Turkey
Location #123
🇹🇷Kocaeli, Turkey
Location #97
🇺🇸Providence, Rhode Island, United States
Location #37
🇨🇦Calgary, Alberta, Canada