Spots Global Cancer Trial Database for A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
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Trial Identification
Brief Title: 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 ID: NCT00395070
Conditions
Study Description
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Liege, , Belgium
Location #102, Itaquera, Sao Paulo, Brazil
Location #99, Belo Horizonte, , Brazil
Location #101, Curitiba, , Brazil
Location #104, Ijui, , Brazil
Location #100, Lajeado, , Brazil
Location #103, Porto Alegre, , Brazil
Location #105, Rio de Janeiro, , Brazil
Location #106, Sao 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 #74, Paris Cedex 10, , France
Location #66, Paris Cedex 18, , France
Location #115, Toulouse, , France
Location #116, Villejuif, , France
Location #90, Augsburg, , Germany
Location #51, Berlin, , Germany
Location #91, Dresden, , Germany
Location #46, Hannover, , Germany
Location #89, Jena, , Germany
Location #50, Kiel, , Germany
Location #48, Lubeck, , Germany
Location #111, Ludwigshafen, , Germany
Location #44, Munster, , Germany
Location #52, Tubingen, , Germany
Location #45, Wurzburg, , Germany
Location #86, Jerusalem, , Israel
Location #84, Petach Tikva, , Israel
Location #85, Tel Hashomer, , Israel
Location #82, Genoa, , Italy
Location #78, Milan, , Italy
Location #79, Napoli, , Italy
Location #80, Padova, , Italy
Location #81, Siena, , Italy
Location #59, Groningen, , Netherlands
Location #60, Leiden, , Netherlands
Location #72, Lubin, , Poland
Location #65, Poznan, , Poland
Location #93, Barnaul, , Russian Federation
Location #61, Moscow, , Russian Federation
Location #58, Moscow, , Russian Federation
Location #62, Nizniy Novogrod, , Russian Federation
Location #94, Samara, , Russian Federation
Location #57, St. Petersburg, , Russian Federation
Location #95, Stavropol, , Russian Federation
Location #67, Barcelona, , Spain
Location #54, Valencia, , Spain
Location #68, Zaragoza, , Spain
Location #118, Bern, , Switzerland
Location #43, Zurich, , Switzerland
Location #122, Ankara, , Turkey
Location #124, Antalya, , Turkey
Location #121, Izmir, , Turkey
Location #123, Kocaeli, , Turkey
Contact Details
Name: Linda Strause, PhD
Affiliation: Vical
Role: STUDY_DIRECTOR
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