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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.

Outcome Time Frame:

After all 375 subjects are enrolled

Safety Issue:

No

Principal Investigator

Linda Strause, PHD

Investigator Role:

Study Director

Investigator Affiliation:

Vical

Authority:

United States: Food and Drug Administration

Study ID:

LX01-315

NCT ID:

NCT00395070

Start Date:

October 2006

Completion Date:

August 2013

Related Keywords:

  • Metastatic Melanoma
  • Melanoma
  • DTIC
  • TMZ
  • Stage 3
  • Stage 4
  • Metastatic
  • Metastatic Melanoma (Stage 3, Stage 4 Melanoma)
  • Melanoma

Name

Location

Location #40Tucson, Arizona  85724
Location #9Little Rock, Arkansas  72205
Location #1Bakersfield, California  93309
Location #24San Diego, California  92093
Location #36San Diego, California  92161
Location #47San Francisco, California  94117
Location #16Denver, Colorado  80045
Location #11Lakeland, Florida  33805
Location #7Chicago, Illinois  60068
Location #33Chicago, Illinois  60612
Location #20Louisville, Kentucky  40202
Location #35Baltimore, Maryland  21202
Location #4Kansas City, Missouri  64111
Location #19St. Louis, Missouri  63110
Location #38Hackensack, New Jersey  07601
Location #8Montclair, New Jersey  07042
Location #87Albuquerque, New Mexico  87131
Location #41Cincinnati, Ohio  45219
Location #23Cleveland, Ohio  44106
Location #34Portland, Oregon  97239
Location #12Bethlehem, Pennsylvania  18015
Location #97Providence, Rhode Island  02903
Location #28Dallas, Texas  75246
Location #117Houston, Texas  77030
Location #26Salt Lake City, Utah  84112
Location #27Salt Lake City, Utah  84103
Location #32Seattle, Washington  98104