Phase II Trial of Allovectin-7® for Metastatic Melanoma

Phase 2

Completed

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

• Registration Number: NCT00044356
• Lead Sponsor: Vical

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 Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-08-26
• Study First Submitted QC: 2002-08-27
• Study First Posted: 2002-08-28
• Primary Completion: 2004-08
• Study Completion: 2004-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-05
• Last Update Posted: 2011-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (16)

Hematology Oncology Associates of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Comprehensive Blood and Cancer Center; 🇺🇸 Bakersfield, California, United States

North Memorial Health Care; 🇺🇸 Robbinsdale, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

The Melanoma Center of Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

Beth Israel Medical Center; 🇺🇸 New York, New York, United States

Louisiana State University Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

University of Arkansas Cancer Research Center; 🇺🇸 Little Rock, Arkansas, United States

Oncology Specialists, S.C.; 🇺🇸 Park Ridge, Illinois, United States

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States