Melanoma Clinical Trial

A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

390

Study ID:

NCT00395070

Recruitment Status:

Completed

Sponsor:

Vical

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There are 78 Locations for this study

See Locations Near You

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
Liege , B 400, Belgium
Location #102
Itaquera Sao Paulo, 08270, Brazil
Location #99
Belo Horizonte , 30-38, Brazil
Location #101
Curitiba , 81520, Brazil
Location #104
Ijui , 98700, Brazil
Location #100
Lajeado , 95900, Brazil
Location #103
Porto Alegre , 90610, Brazil
Location #105
Rio de Janeiro , 20230, Brazil
Location #106
Sao Paulo , , Brazil
Location #37
Calgary Alberta, T2N 4, Canada
Location #88
Winnipeg Manitoba, R3E 0, Canada
Location # 75
Ottawa Ontario, K1H 8, 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 #74
Paris Cedex 10 , , France
Location #66
Paris Cedex 18 , , 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
Hannover , 30449, Germany
Location #89
Jena , , Germany
Location #50
Kiel , 24105, Germany
Location #48
Lubeck , 23538, Germany
Location #111
Ludwigshafen , 67063, Germany
Location #44
Munster , 48149, Germany
Location #52
Tubingen , 72076, Germany
Location #45
Wurzburg , 97080, Germany
Location #86
Jerusalem , 91120, Israel
Location #84
Petach Tikva , 49100, Israel
Location #85
Tel Hashomer , 52621, Israel
Location #82
Genoa , , Italy
Location #78
Milan , 20141, Italy
Location #79
Napoli , , Italy
Location #80
Padova , 35128, Italy
Location #81
Siena , , Italy
Location #59
Groningen , 9713 , Netherlands
Location #60
Leiden , 2333, Netherlands
Location #72
Lubin , 59-30, Poland
Location #65
Poznan , 61-86, Poland
Location #93
Barnaul , 65604, Russian Federation
Location #61
Moscow , 11547, Russian Federation
Location #58
Moscow , 14390, Russian Federation
Location #62
Nizniy Novogrod , 60300, Russian Federation
Location #94
Samara , 44306, Russian Federation
Location #57
St. Petersburg , 19775, Russian Federation
Location #95
Stavropol , , Russian Federation
Location #67
Barcelona , 08036, Spain
Location #54
Valencia , 46014, Spain
Location #68
Zaragoza , 50009, Spain
Location #118
Bern , CH-30, Switzerland
Location #43
Zurich , 8091, Switzerland
Location #122
Ankara , 06590, Turkey
Location #124
Antalya , 07070, Turkey
Location #121
Izmir , 35100, Turkey
Location #123
Kocaeli , 41400, Turkey

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

390

Study ID:

NCT00395070

Recruitment Status:

Completed

Sponsor:


Vical

How clear is this clinincal trial information?

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