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

PHASE3CompletedINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

March 31, 2012

Study Completion Date

July 31, 2013

Conditions
Metastatic Melanoma
Interventions
BIOLOGICAL

Allovectin-7®

Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.

DRUG

Dacarbazine (DTIC)

1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR

DRUG

Temozolomide (TMZ)

150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Trial Locations (88)

1200

Location #55, Brussels

2333

Location #60, Leiden

8091

Location #43, Zurich

10117

Location #51, Berlin

13009

Location #113, Marseille

18015

Location #12, Bethlehem

20141

Location #78, Milan

21202

Location #35, Baltimore

23538

Location #48, Lübeck

24105

Location #50, Kiel

30449

Location #46, Hanover

31059

Location #115, Toulouse

33075

Location #110, Bordeaux

33805

Location #11, Lakeland

34295

Location #114, Montpellier

35100

Location #121, Izmir

35128

Location #80, Padua

40202

Location #20, Louisville

41400

Location #123, Kocaeli

44093

Location #109, Nantes

44106

Location #23, Cleveland

45219

Location #41, Cincinnati

46014

Location #54, Valencia

48149

Location #44, Münster

49100

Location #84, Petah Tikva

50009

Location #68, Zaragoza

52621

Location #85, Tel Litwinsky

60068

Location #7, Chicago

60612

Location #33, Chicago

63110

Location #19, St Louis

64111

Location #4, Kansas City

67063

Location #111, Ludwigshafen

69495

Location #112, Lyon

72076

Location #52, Tübingen

72205

Location #9, Little Rock

75246

Location #28, Dallas

77030

Location #117, Houston

80045

Location #16, Denver

84103

Location #27, Salt Lake City

84112

Location #26, Salt Lake City

85724

Location #40, Tucson

87131

Location #87, Albuquerque

91120

Location #86, Jerusalem

92093

Location #24, San Diego

92161

Location #36, San Diego

93309

Location #1, Bakersfield

94117

Location #47, San Francisco

94800

Location #116, Villejuif

97080

Location #45, Würzburg

97239

Location #34, Portland

98104

Location #32, Seattle

115478

Location #61, Moscow

143900

Location #58, Moscow

197758

Location #57, Saint Petersburg

443066

Location #94, Samara

603000

Location #62, Nizniy Novogrod

656049

Location #93, Barnaul

07601

Location #38, Hackensack

07042

Location #8, Montclair

02903

Location #97, Providence

B 4000

Location #63, Liège

08270-070

Location #102, Itaquera

30-380-490

Location #99, Belo Horizonte

81520-060

Location #101, Curitiba

98700-000

Location #104, Ijuí

95900-000

Location #100, Lajeado

90610-000

Location #103, Porto Alegre

20230-0130

Location #105, Rio de Janeiro

Unknown

Location #106, São Paulo

Location #66, Paris

Location #74, Paris

Location #90, Augsburg

Location #91, Dresden

Location #89, Jena

Location #82, Genoa

Location #79, Napoli

Location #81, Siena

Location #95, Stavropol

T2N 4N2

Location #37, Calgary

R3E 0V9

Location #88, Winnipeg

K1H 8L6

Location # 75, Ottawa

9713 GZ

Location #59, Groningen

59-301

Location #72, Lubin

61-866

Location #65, Poznan

08036

Location #67, Barcelona

CH-3010

Location #118, Bern

06590

Location #122, Ankara

07070

Location #124, Antalya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Vical

INDUSTRY

NCT00395070 - A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma | Biotech Hunter | Biotech Hunter