Phase II Trial of Allovectin-7® for Metastatic Melanoma

Vical

Status and phase: Completed; Phase 2

Conditions: Melanoma; Malignant Melanoma; Skin Cancer; Metastatic Melanoma

Treatments: Genetic: Allovectin-7®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00044356

VCL-1005-208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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