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Trial record 1 of 5 for:    allovectin-7
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A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vical
ClinicalTrials.gov Identifier:
NCT00395070
First received: October 31, 2006
Last updated: September 11, 2013
Last verified: September 2013
  Purpose
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.

Condition Intervention Phase
Metastatic Melanoma
Biological: Allovectin-7®
Drug: Dacarbazine (DTIC)
Drug: Temozolomide (TMZ)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vical:

Primary Outcome Measures:
  • To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm. [ Time Frame: After all 375 subjects are enrolled ]

Secondary Outcome Measures:
  • To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. [ Time Frame: After all 375 subjects are enrolled ]
  • To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. [ Time Frame: After all 375 subjects are enrolled ]

Enrollment: 390
Study Start Date: October 2006
Study Completion Date: July 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Biological: Allovectin-7®
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
Active Comparator: Control Arm
DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395070

  Hide Study Locations
Locations
United States, Arizona
Location #40
Tucson, Arizona, United States, 85724
United States, Arkansas
Location #9
Little Rock, Arkansas, United States, 72205
United States, California
Location #1
Bakersfield, California, United States, 93309
Location #24
San Diego, California, United States, 92093
Location #36
San Diego, California, United States, 92161
Location #47
San Francisco, California, United States, 94117
United States, Colorado
Location #16
Denver, Colorado, United States, 80045
United States, Florida
Location #11
Lakeland, Florida, United States, 33805
United States, Illinois
Location #7
Chicago, Illinois, United States, 60068
Location #33
Chicago, Illinois, United States, 60612
United States, Kentucky
Location #20
Louisville, Kentucky, United States, 40202
United States, Maryland
Location #35
Baltimore, Maryland, United States, 21202
United States, Missouri
Location #4
Kansas City, Missouri, United States, 64111
Location #19
St. Louis, Missouri, United States, 63110
United States, New Jersey
Location #38
Hackensack, New Jersey, United States, 07601
Location #8
Montclair, New Jersey, United States, 07042
United States, New Mexico
Location #87
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Location #41
Cincinnati, Ohio, United States, 45219
Location #23
Cleveland, Ohio, United States, 44106
United States, Oregon
Location #34
Portland, Oregon, United States, 97239
United States, Pennsylvania
Location #12
Bethlehem, Pennsylvania, United States, 18015
United States, Rhode Island
Location #97
Providence, Rhode Island, United States, 02903
United States, Texas
Location #28
Dallas, Texas, United States, 75246
Location #117
Houston, Texas, United States, 77030
United States, Utah
Location #27
Salt Lake City, Utah, United States, 84103
Location #26
Salt Lake City, Utah, United States, 84112
United States, Washington
Location #32
Seattle, Washington, United States, 98104
Belgium
Location #55
Brussels, Belgium, 1200
Location #63
Liege, Belgium, B 4000
Brazil
Location #102
Itaquera, Sao Paulo, Brazil, 08270-070
Location #99
Belo Horizonte, Brazil, 30-380-490
Location #101
Curitiba, Brazil, 81520-060
Location #104
Ijui, Brazil, 98700-000
Location #100
Lajeado, Brazil, 95900-000
Location #103
Porto Alegre, Brazil, 90610-000
Location #105
Rio de Janeiro, Brazil, 20230-0130
Location #106
Sao Paulo, Brazil
Canada, Alberta
Location #37
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Location #88
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Location # 75
Ottawa, Ontario, Canada, K1H 8L6
France
Location #110
Bordeaux, France, 33075
Location #112
Lyon, France, 69495
Location #113
Marseille, France, 13009
Location #114
Montpellier, France, 34295
Location #109
Nantes, France, 44093
Location #74
Paris Cedex 10, France
Location #66
Paris Cedex 18, France
Location #115
Toulouse, France, 31059
Location #116
Villejuif, France, 94800
Germany
Location #90
Augsburg, Germany
Location #51
Berlin, Germany, 10117
Location #91
Dresden, Germany
Location #46
Hannover, Germany, 30449
Location #89
Jena, Germany
Location #50
Kiel, Germany, 24105
Location #48
Lubeck, Germany, 23538
Location #111
Ludwigshafen, Germany, 67063
Location #44
Munster, Germany, 48149
Location #52
Tubingen, Germany, 72076
Location #45
Wurzburg, Germany, 97080
Israel
Location #86
Jerusalem, Israel, 91120
Location #84
Petach Tikva, Israel, 49100
Location #85
Tel Hashomer, Israel, 52621
Italy
Location #82
Genoa, Italy
Location #78
Milan, Italy, 20141
Location #79
Napoli, Italy
Location #80
Padova, Italy, 35128
Location #81
Siena, Italy
Netherlands
Location #59
Groningen, Netherlands, 9713 GZ
Location #60
Leiden, Netherlands, 2333
Poland
Location #72
Lubin, Poland, 59-301
Location #65
Poznan, Poland, 61-866
Russian Federation
Location #93
Barnaul, Russian Federation, 656049
Location #61
Moscow, Russian Federation, 115478
Location #58
Moscow, Russian Federation, 143900
Location #62
Nizniy Novogrod, Russian Federation, 603000
Location #94
Samara, Russian Federation, 443066
Location #57
St. Petersburg, Russian Federation, 197758
Location #95
Stavropol, Russian Federation
Spain
Location #67
Barcelona, Spain, 08036
Location #54
Valencia, Spain, 46014
Location #68
Zaragoza, Spain, 50009
Switzerland
Location #118
Bern, Switzerland, CH-3010
Location #43
Zurich, Switzerland, 8091
Turkey
Location #122
Ankara, Turkey, 06590
Location #124
Antalya, Turkey, 07070
Location #121
Izmir, Turkey, 35100
Location #123
Kocaeli, Turkey, 41400
Sponsors and Collaborators
Vical
Investigators
Study Director: Linda Strause, PhD Vical
  More Information

Additional Information:
Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT00395070     History of Changes
Other Study ID Numbers: LX01-315
Study First Received: October 31, 2006
Last Updated: September 11, 2013

Keywords provided by Vical:
Melanoma
DTIC
TMZ
Stage 3
Stage 4
Metastatic
Metastatic Melanoma (Stage 3, Stage 4 Melanoma)

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 24, 2017