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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395070
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : September 13, 2013
Information provided by (Responsible Party):

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.

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

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  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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.

Primary Outcome Measures :
  1. 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 :
  1. To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. [ Time Frame: After all 375 subjects are enrolled ]
  2. To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. [ Time Frame: After all 375 subjects are enrolled ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395070

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United States, Arizona
Location #40
Tucson, Arizona, United States, 85724
United States, Arkansas
Location #9
Little Rock, Arkansas, United States, 72205
United States, California
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Bakersfield, California, United States, 93309
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Denver, Colorado, United States, 80045
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Lakeland, Florida, United States, 33805
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Chicago, Illinois, United States, 60068
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Chicago, Illinois, United States, 60612
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Louisville, Kentucky, United States, 40202
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Baltimore, Maryland, United States, 21202
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Kansas City, Missouri, United States, 64111
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St. Louis, Missouri, United States, 63110
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Hackensack, New Jersey, United States, 07601
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Montclair, New Jersey, United States, 07042
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Albuquerque, New Mexico, United States, 87131
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44106
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Portland, Oregon, United States, 97239
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Bethlehem, Pennsylvania, United States, 18015
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Providence, Rhode Island, United States, 02903
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Dallas, Texas, United States, 75246
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Houston, Texas, United States, 77030
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Villejuif, France, 94800
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Hannover, Germany, 30449
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Kiel, Germany, 24105
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Lubeck, Germany, 23538
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Tubingen, Germany, 72076
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Wurzburg, Germany, 97080
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Tel Hashomer, Israel, 52621
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Barnaul, Russian Federation, 656049
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Moscow, Russian Federation, 143900
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Nizniy Novogrod, Russian Federation, 603000
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Stavropol, Russian Federation
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Valencia, Spain, 46014
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Zaragoza, Spain, 50009
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Bern, Switzerland, CH-3010
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Zurich, Switzerland, 8091
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Ankara, Turkey, 06590
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Antalya, Turkey, 07070
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Izmir, Turkey, 35100
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Kocaeli, Turkey, 41400
Sponsors and Collaborators
Study Director: Linda Strause, PhD Vical

Additional Information:
Responsible Party: Vical Identifier: NCT00395070     History of Changes
Other Study ID Numbers: LX01-315
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

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

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