Phase II Trial of Allovectin-7® for Metastatic Melanoma

July 5, 2011 updated by: Vical

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas Cancer Research Center
    • California
      • Bakersfield, California, United States, 48202
        • Comprehensive Blood and Cancer Center
      • San Francisco, California, United States, 94115
        • University of California, San Francisco
    • Colorado
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Hematology Oncology Associates of Baltimore
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Health Care
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • The Melanoma Center of Saint Louis
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

August 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

August 26, 2002

First Submitted That Met QC Criteria

August 27, 2002

First Posted (Estimate)

August 28, 2002

Study Record Updates

Last Update Posted (Estimate)

July 7, 2011

Last Update Submitted That Met QC Criteria

July 5, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCL-1005-208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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