Clinical trial NCT00395070: A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Melanoma
Keywords: Melanoma
DTIC
TMZ
Stage 3
Stage 4
Metastatic
Metastatic Melanoma (Stage 3, Stage 4 Melanoma)
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria (Potential study participants must meet the following criteria):

* 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

Exclusion Criteria (Potential study participants will not be eligible with the following):

* 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

Primary outcomes:
measure: To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.
timeFrame: After all 375 subjects are enrolled
Secondary outcomes:
measure: To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
timeFrame: After all 375 subjects are enrolled
measure: To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.
timeFrame: After all 375 subjects are enrolled
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Location #40
state: Arizona
city: Little Rock
country: United States
facility: Location #9
state: Arkansas
city: Bakersfield
country: United States
facility: Location #1
state: California
city: San Diego
country: United States
facility: Location #24
state: California
city: San Diego
country: United States
facility: Location #36
state: California
city: San Francisco
country: United States
facility: Location #47
state: California
city: Denver
country: United States
facility: Location #16
state: Colorado
city: Lakeland
country: United States
facility: Location #11
state: Florida
city: Chicago
country: United States
facility: Location #7
state: Illinois
city: Chicago
country: United States
facility: Location #33
state: Illinois
city: Louisville
country: United States
facility: Location #20
state: Kentucky
city: Baltimore
country: United States
facility: Location #35
state: Maryland
city: Kansas City
country: United States
facility: Location #4
state: Missouri
city: St. Louis
country: United States
facility: Location #19
state: Missouri
city: Hackensack
country: United States
facility: Location #38
state: New Jersey
city: Montclair
country: United States
facility: Location #8
state: New Jersey
city: Albuquerque
country: United States
facility: Location #87
state: New Mexico
city: Cincinnati
country: United States
facility: Location #41
state: Ohio
city: Cleveland
country: United States
facility: Location #23
state: Ohio
city: Portland
country: United States
facility: Location #34
state: Oregon
city: Bethlehem
country: United States
facility: Location #12
state: Pennsylvania
city: Providence
country: United States
facility: Location #97
state: Rhode Island
city: Dallas
country: United States
facility: Location #28
state: Texas
city: Houston
country: United States
facility: Location #117
state: Texas
city: Salt Lake City
country: United States
facility: Location #27
state: Utah
city: Salt Lake City
country: United States
facility: Location #26
state: Utah
city: Seattle
country: United States
facility: Location #32
state: Washington
city: Brussels
country: Belgium
facility: Location #55
city: Liege
country: Belgium
facility: Location #63
city: Itaquera
country: Brazil
facility: Location #102
state: Sao Paulo
city: Belo Horizonte
country: Brazil
facility: Location #99
city: Curitiba
country: Brazil
facility: Location #101
city: Ijui
country: Brazil
facility: Location #104
city: Lajeado
country: Brazil
facility: Location #100
city: Porto Alegre
country: Brazil
facility: Location #103
city: Rio de Janeiro
country: Brazil
facility: Location #105
city: Sao Paulo
country: Brazil
facility: Location #106
city: Calgary
country: Canada
facility: Location #37
state: Alberta
city: Winnipeg
country: Canada
facility: Location #88
state: Manitoba
city: Ottawa
country: Canada
facility: Location # 75
state: Ontario
city: Bordeaux
country: France
facility: Location #110
city: Lyon
country: France
facility: Location #112
city: Marseille
country: France
facility: Location #113
city: Montpellier
country: France
facility: Location #114
city: Nantes
country: France
facility: Location #109
city: Paris Cedex 10
country: France
facility: Location #74
city: Paris Cedex 18
country: France
facility: Location #66
city: Toulouse
country: France
facility: Location #115
city: Villejuif
country: France
facility: Location #116
city: Augsburg
country: Germany
facility: Location #90
city: Berlin
country: Germany
facility: Location #51
city: Dresden
country: Germany
facility: Location #91
city: Hannover
country: Germany
facility: Location #46
city: Jena
country: Germany
facility: Location #89
city: Kiel
country: Germany
facility: Location #50
city: Lubeck
country: Germany
facility: Location #48
city: Ludwigshafen
country: Germany
facility: Location #111
city: Munster
country: Germany
facility: Location #44
city: Tubingen
country: Germany
facility: Location #52
city: Wurzburg
country: Germany
facility: Location #45
city: Jerusalem
country: Israel
facility: Location #86
city: Petach Tikva
country: Israel
facility: Location #84
city: Tel Hashomer
country: Israel
facility: Location #85
city: Genoa
country: Italy
facility: Location #82
city: Milan
country: Italy
facility: Location #78
city: Napoli
country: Italy
facility: Location #79
city: Padova
country: Italy
facility: Location #80
city: Siena
country: Italy
facility: Location #81
city: Groningen
country: Netherlands
facility: Location #59
city: Leiden
country: Netherlands
facility: Location #60
city: Lubin
country: Poland
facility: Location #72
city: Poznan
country: Poland
facility: Location #65
city: Barnaul
country: Russian Federation
facility: Location #93
city: Moscow
country: Russian Federation
facility: Location #61
city: Moscow
country: Russian Federation
facility: Location #58
city: Nizniy Novogrod
country: Russian Federation
facility: Location #62
city: Samara
country: Russian Federation
facility: Location #94
city: St. Petersburg
country: Russian Federation
facility: Location #57
city: Stavropol
country: Russian Federation
facility: Location #95
city: Barcelona
country: Spain
facility: Location #67
city: Valencia
country: Spain
facility: Location #54
city: Zaragoza
country: Spain
facility: Location #68
city: Bern
country: Switzerland
facility: Location #118
city: Zurich
country: Switzerland
facility: Location #43
city: Ankara
country: Turkey
facility: Location #122
city: Antalya
country: Turkey
facility: Location #124
city: Izmir
country: Turkey
facility: Location #121
city: Kocaeli
country: Turkey
facility: Location #123
Study officials:
affiliation: Vical
name: Linda Strause, PhD
role: STUDY_DIRECTOR
References: