A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone & Chemotherapy Alone in Subjects With Stage 3 or Stage 4 Melanoma
This study is currently recruiting patients.
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.
Eligible patients will have a 2 to 1 chance to receive Allovectin-7®, an investigational drug, over traditional chemotherapy (either 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 into a selected lesion for six weeks followed by two weeks of observation and assessments. For patients who receive traditional chemotherapy alone their treatment course will follow standard dosing. During the trial all patients’ tumor lesions and disease progression will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed every eight weeks for up to a year.
Ages Eligible for Study: 18 Years and above,
Genders Eligible for Study: Both
Inclusion Criteria (Potential participants must meet the following criteria):
1. Confirmed Stage 3 or Stage 4 Melanoma which may have had previous treatment via surgery, radiation or biologic drugs (typically IFNa or IL2)
2. At least 1 melanoma lesion that is injectable and 1cm x 1cm or greater in size
3. Normal blood chemistries and blood cell counts
4. Able and willing to provide informed consent
Exclusion Criteria (Potential participants will not be eligible with the following):
1. Previous chemotherapy treatment for melanoma
2. Melanoma lesions in the brain or liver (however lesions in the lungs are allowed)
3. If surgical removal of all lesions would be viable and potentially curative as judged by the patient's physician
4. Any melanoma lesions greater than 10cm x 10cm in size
5. Known condition resulting in immunosuppression
6. Significant psychiatric disorders that would make compliance difficult or would compromise ability to give informed consent
7. Female subjects who are pregnant
Location and Contact Information
Cathleen Schaeffer: 312-413-3863