Melanoma Clinical Trial
A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
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.
Full 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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 78 Locations for this study
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Bakersfield California, 93309, United States
San Diego California, 92093, United States
San Diego California, 92161, United States
San Francisco California, 94117, United States
Denver Colorado, 80045, United States
Lakeland Florida, 33805, United States
Chicago Illinois, 60068, United States
Chicago Illinois, 60612, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21202, United States
Kansas City Missouri, 64111, United States
St. Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
Montclair New Jersey, 07042, United States
Albuquerque New Mexico, 87131, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97239, United States
Bethlehem Pennsylvania, 18015, United States
Providence Rhode Island, 02903, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84103, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98104, United States
Brussels , 1200, Belgium
Liege , B 400, Belgium
Itaquera Sao Paulo, 08270, Brazil
Belo Horizonte , 30-38, Brazil
Curitiba , 81520, Brazil
Ijui , 98700, Brazil
Lajeado , 95900, Brazil
Porto Alegre , 90610, Brazil
Rio de Janeiro , 20230, Brazil
Sao Paulo , , Brazil
Calgary Alberta, T2N 4, Canada
Winnipeg Manitoba, R3E 0, Canada
Ottawa Ontario, K1H 8, Canada
Bordeaux , 33075, France
Lyon , 69495, France
Marseille , 13009, France
Montpellier , 34295, France
Nantes , 44093, France
Paris Cedex 10 , , France
Paris Cedex 18 , , France
Toulouse , 31059, France
Villejuif , 94800, France
Augsburg , , Germany
Berlin , 10117, Germany
Dresden , , Germany
Hannover , 30449, Germany
Jena , , Germany
Kiel , 24105, Germany
Lubeck , 23538, Germany
Ludwigshafen , 67063, Germany
Munster , 48149, Germany
Tubingen , 72076, Germany
Wurzburg , 97080, Germany
Jerusalem , 91120, Israel
Petach Tikva , 49100, Israel
Tel Hashomer , 52621, Israel
Genoa , , Italy
Milan , 20141, Italy
Napoli , , Italy
Padova , 35128, Italy
Siena , , Italy
Groningen , 9713 , Netherlands
Leiden , 2333, Netherlands
Lubin , 59-30, Poland
Poznan , 61-86, Poland
Barnaul , 65604, Russian Federation
Moscow , 11547, Russian Federation
Moscow , 14390, Russian Federation
Nizniy Novogrod , 60300, Russian Federation
Samara , 44306, Russian Federation
St. Petersburg , 19775, Russian Federation
Stavropol , , Russian Federation
Barcelona , 08036, Spain
Valencia , 46014, Spain
Zaragoza , 50009, Spain
Bern , CH-30, Switzerland
Zurich , 8091, Switzerland
Ankara , 06590, Turkey
Antalya , 07070, Turkey
Izmir , 35100, Turkey
Kocaeli , 41400, Turkey
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.