Phase II Trial of Allovectin-7® for Metastatic Melanoma

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.

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Key information

Conditions

Melanoma Malignant Melanoma Metastatic Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Cancer Center, Tucson, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allovectin-7®

Genetic

Sponsors and collaborators

Lead sponsor

Vical

Industry

Registry information

Official study title

A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma

Important dates

Study start: 2001
Primary completion: 2004
Study completion: 2004
First posted: Aug 28, 2002
Registry last updated: Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed