Malignant Melanoma, Melanoma, Metastatic Melanoma, Skin Cancer
Conditions
Keywords
Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer, Tumor, Experimental Treatment, Clinical Trial, Gene Therapy, Gene Delivery, Gene Transfer, Immunotherapy, Cancer, Neoplasm, Lesion, Metastasis, Cancerous mole, Melanoma vaccine, Cancer research, Cancer cells, Allovectin-7®
Brief summary
The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.
Detailed description
Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.
Interventions
GENETICAllovectin-7®
Sponsors
Vical
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria. * You have been diagnosed with Stage III or Stage IV melanoma * Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or you refused therapy with standard treatment * You are able to carry out your normal daily activities * Your melanoma has not spread to your brain
Countries
United States
Outcome results
None listed