Allovectin-7®: The A.I.M.M. Trial
Primary Objective of the Trial
To compare the overall response rate at > 24 weeks after randomization in the Allovectin-7® group versus the control group [dacarbazine (DTIC) or temozolomide (TMZ)].
Expected Total Enrollment: 375
Allovectin-7®
An investigational product designed to train the body's immune system to recognize and destroy tumor cells, both local and distant (metastatic).
Trial Details
Eligible patients will be randomized (like a roll of the dice) by computer into one of two treatment groups in the trial, either the Allovectin-7® group or the chemotherapy (DTIC or TMZ) group. Patients will have a 66% chance of receiving Allovectin-7® vs. a 33% chance of receiving standard chemotherapy (DTIC or TMZ). 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' melanoma will be closely monitored by physical exam, CT or MRI scans, and laboratory tests of their blood. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.
Key Eligibility Criteria
- Confirmed Stage 3 or Stage 4 melanoma
- No prior use of chemotherapy for treatment of melanoma
This clinical trial is currently enrolling patients in the following cities (alphabetical order by state):
North America
United States
AL, Mobile
AR, Little Rock
AZ, Tucson
CA, Bakersfield
CA, Los Angeles
CA, San Diego
CO, Denver
FL, Ft. Lauderdale area
FL, Tampa Bay area
FL, West Palm Beach area (Jupiter)
IL, Chicago
KY, Louisville
MD, Baltimore
MN, Minneapolis
MN, Rochester
MO, Kansas City
MO, Jefferson City (mid-state)
MO, St. Louis
NJ, Newark (Montclair)
NJ, Hackensack
NC, Goldsboro (SE of Raleigh)
NY, New York
OH, Cincinnati
OH, Cleveland
OH, Dayton
OK, Oklahoma City
OR, Portland
PA, Philadelphia (Bethlehem)
SC, Spartanburg
TX, Dallas
UT, Salt Lake City
WA, Seattle
Canada
Alberta, Calgary
Nova Scotia, Halifax
Europe/Asia/Middle East
Germany
Berlin
Hannover
Kiel
Lubeck
Munster
Tubingen
Wurzburg
Switzerland
Zurich
Sites in the following cities are expected to start enrolling patients within 6 months (alphabetical order by state):
United States
AZ, Scottsdale
CA, San Francisco
CA, Davis
WI, Madison
Canada
Quebec, Montreal
Nova Scotia, Halifax
Europe/Asia/Middle East
Belgium
Croatia
France
Israel
Italy
Netherlands
Poland
Russia
Spain
South America
Brazil
To find out if you, or someone you know, may qualify to participate in this trial, please click below. This link will take you to a trial-specific website where you will be able to answer a series of questions to see if you may qualify for the study. You will be under no obligation to participate in the trial.