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

Metastatic Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395070
• Other study ID #: LX01-315
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2006
• Last updated: September 11, 2013
• Start date: October 2006
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: July 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

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
• Temozolomide (TMZ)
150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Locations

Country	Name	City	State
Belgium	Location #55	Brussels
Belgium	Location #63	Liege
Brazil	Location #99	Belo Horizonte
Brazil	Location #101	Curitiba
Brazil	Location #104	Ijui
Brazil	Location #102	Itaquera	Sao Paulo
Brazil	Location #100	Lajeado
Brazil	Location #103	Porto Alegre
Brazil	Location #105	Rio de Janeiro
Brazil	Location #106	Sao Paulo
Canada	Location #37	Calgary	Alberta
Canada	Location # 75	Ottawa	Ontario
Canada	Location #88	Winnipeg	Manitoba
France	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
Germany	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
Israel	Location #86	Jerusalem
Israel	Location #84	Petach Tikva
Israel	Location #85	Tel Hashomer
Italy	Location #82	Genoa
Italy	Location #78	Milan
Italy	Location #79	Napoli
Italy	Location #80	Padova
Italy	Location #81	Siena
Netherlands	Location #59	Groningen
Netherlands	Location #60	Leiden
Poland	Location #72	Lubin
Poland	Location #65	Poznan
Russian Federation	Location #93	Barnaul
Russian Federation	Location #58	Moscow
Russian Federation	Location #61	Moscow
Russian Federation	Location #62	Nizniy Novogrod
Russian Federation	Location #94	Samara
Russian Federation	Location #57	St. Petersburg
Russian Federation	Location #95	Stavropol
Spain	Location #67	Barcelona
Spain	Location #54	Valencia
Spain	Location #68	Zaragoza
Switzerland	Location #118	Bern
Switzerland	Location #43	Zurich
Turkey	Location #122	Ankara
Turkey	Location #124	Antalya
Turkey	Location #121	Izmir
Turkey	Location #123	Kocaeli
United States	Location #87	Albuquerque	New Mexico
United States	Location #1	Bakersfield	California
United States	Location #35	Baltimore	Maryland
United States	Location #12	Bethlehem	Pennsylvania
United States	Location #33	Chicago	Illinois
United States	Location #7	Chicago	Illinois
United States	Location #41	Cincinnati	Ohio
United States	Location #23	Cleveland	Ohio
United States	Location #28	Dallas	Texas
United States	Location #16	Denver	Colorado
United States	Location #38	Hackensack	New Jersey
United States	Location #117	Houston	Texas
United States	Location #4	Kansas City	Missouri
United States	Location #11	Lakeland	Florida
United States	Location #9	Little Rock	Arkansas
United States	Location #20	Louisville	Kentucky
United States	Location #8	Montclair	New Jersey
United States	Location #34	Portland	Oregon
United States	Location #97	Providence	Rhode Island
United States	Location #26	Salt Lake City	Utah
United States	Location #27	Salt Lake City	Utah
United States	Location #24	San Diego	California
United States	Location #36	San Diego	California
United States	Location #47	San Francisco	California
United States	Location #32	Seattle	Washington
United States	Location #19	St. Louis	Missouri
United States	Location #40	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.		After all 375 subjects are enrolled	Yes
Secondary	To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.		After all 375 subjects are enrolled	No

External Links

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