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