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

September 11, 2013 updated by: Vical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After all 375 subjects are enrolled

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
Time Frame: After all 375 subjects are enrolled
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
After all 375 subjects are enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vical

Investigators

  • Study Director: Linda Strause, PhD, Vical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 11, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX01-315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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