Phase II Trial of Allovectin-7® for Metastatic Melanoma

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044356
• Other study ID #: VCL-1005-208
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2002
• Last updated: July 5, 2011
• Start date: February 2001
• Est. completion date: September 2004

Study information

• Verified date: July 2011
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00028444

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma
• Metastatic Melanoma
• Skin Cancer
• Skin Neoplasms

Intervention

Genetic:
• Allovectin-7®

Locations

Country	Name	City	State
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Hematology Oncology Associates of Baltimore	Baltimore	Maryland
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas Cancer Research Center	Little Rock	Arkansas
United States	Louisiana State University Medical Center	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Oncology Specialists, S.C.	Park Ridge	Illinois
United States	North Memorial Health Care	Robbinsdale	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	The Melanoma Center of Saint Louis	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Cancer Care Alliance	Seattle	Washington
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Country where clinical trial is conducted

United States, 

External Links

•   Link