A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Vical
- Enrollment
- 133
- Locations
- 32
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided