A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma
1 other identifier
interventional
390
14 countries
88
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2006
Longer than P75 for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 31, 2006
CompletedFirst Posted
Study publicly available on registry
November 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedSeptember 13, 2013
September 1, 2013
5.4 years
October 31, 2006
September 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Treatment Arm
EXPERIMENTALAllovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Control Arm
ACTIVE COMPARATORDTIC 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.
Interventions
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
Eligibility Criteria
You may qualify if:
- Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)
- 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
You may not qualify if:
- Previous chemotherapy treatment for melanoma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vicallead
Study Sites (88)
Location #40
Tucson, Arizona, 85724, United States
Location #9
Little Rock, Arkansas, 72205, United States
Location #1
Bakersfield, California, 93309, United States
Location #24
San Diego, California, 92093, United States
Location #36
San Diego, California, 92161, United States
Location #47
San Francisco, California, 94117, United States
Location #16
Denver, Colorado, 80045, United States
Location #11
Lakeland, Florida, 33805, United States
Location #7
Chicago, Illinois, 60068, United States
Location #33
Chicago, Illinois, 60612, United States
Location #20
Louisville, Kentucky, 40202, United States
Location #35
Baltimore, Maryland, 21202, United States
Location #4
Kansas City, Missouri, 64111, United States
Location #19
St Louis, Missouri, 63110, United States
Location #38
Hackensack, New Jersey, 07601, United States
Location #8
Montclair, New Jersey, 07042, United States
Location #87
Albuquerque, New Mexico, 87131, United States
Location #41
Cincinnati, Ohio, 45219, United States
Location #23
Cleveland, Ohio, 44106, United States
Location #34
Portland, Oregon, 97239, United States
Location #12
Bethlehem, Pennsylvania, 18015, United States
Location #97
Providence, Rhode Island, 02903, United States
Location #28
Dallas, Texas, 75246, United States
Location #117
Houston, Texas, 77030, United States
Location #27
Salt Lake City, Utah, 84103, United States
Location #26
Salt Lake City, Utah, 84112, United States
Location #32
Seattle, Washington, 98104, United States
Location #55
Brussels, 1200, Belgium
Location #63
Liège, B 4000, Belgium
Location #102
Itaquera, São Paulo, 08270-070, Brazil
Location #99
Belo Horizonte, 30-380-490, Brazil
Location #101
Curitiba, 81520-060, Brazil
Location #104
Ijuí, 98700-000, Brazil
Location #100
Lajeado, 95900-000, Brazil
Location #103
Porto Alegre, 90610-000, Brazil
Location #105
Rio de Janeiro, 20230-0130, Brazil
Location #106
São Paulo, Brazil
Location #37
Calgary, Alberta, T2N 4N2, Canada
Location #88
Winnipeg, Manitoba, R3E 0V9, Canada
Location # 75
Ottawa, Ontario, K1H 8L6, Canada
Location #110
Bordeaux, 33075, France
Location #112
Lyon, 69495, France
Location #113
Marseille, 13009, France
Location #114
Montpellier, 34295, France
Location #109
Nantes, 44093, France
Location #66
Paris, France
Location #74
Paris, France
Location #115
Toulouse, 31059, France
Location #116
Villejuif, 94800, France
Location #90
Augsburg, Germany
Location #51
Berlin, 10117, Germany
Location #91
Dresden, Germany
Location #46
Hanover, 30449, Germany
Location #89
Jena, Germany
Location #50
Kiel, 24105, Germany
Location #111
Ludwigshafen, 67063, Germany
Location #48
Lübeck, 23538, Germany
Location #44
Münster, 48149, Germany
Location #52
Tübingen, 72076, Germany
Location #45
Würzburg, 97080, Germany
Location #86
Jerusalem, 91120, Israel
Location #84
Petah Tikva, 49100, Israel
Location #85
Tel Litwinsky, 52621, Israel
Location #82
Genoa, Italy
Location #78
Milan, 20141, Italy
Location #79
Napoli, Italy
Location #80
Padua, 35128, Italy
Location #81
Siena, Italy
Location #59
Groningen, 9713 GZ, Netherlands
Location #60
Leiden, 2333, Netherlands
Location #72
Lubin, 59-301, Poland
Location #65
Poznan, 61-866, Poland
Location #93
Barnaul, 656049, Russia
Location #61
Moscow, 115478, Russia
Location #58
Moscow, 143900, Russia
Location #62
Nizniy Novogrod, 603000, Russia
Location #57
Saint Petersburg, 197758, Russia
Location #94
Samara, 443066, Russia
Location #95
Stavropol, Russia
Location #67
Barcelona, 08036, Spain
Location #54
Valencia, 46014, Spain
Location #68
Zaragoza, 50009, Spain
Location #118
Bern, CH-3010, Switzerland
Location #43
Zurich, 8091, Switzerland
Location #122
Ankara, 06590, Turkey (Türkiye)
Location #124
Antalya, 07070, Turkey (Türkiye)
Location #121
Izmir, 35100, Turkey (Türkiye)
Location #123
Kocaeli, 41400, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Linda Strause, PhD
Vical
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2006
First Posted
November 2, 2006
Study Start
October 1, 2006
Primary Completion
March 1, 2012
Study Completion
July 1, 2013
Last Updated
September 13, 2013
Record last verified: 2013-09