Phase II Trial of Allovectin-7® for Metastatic Melanoma

Sponsor

Vical (Industry)

Overall Status

Completed

CT.gov ID

NCT00044356

Collaborator

(none)

133

Enrollment

Locations

Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Metastatic Melanoma Malignant Melanoma Skin Cancer	Genetic: Allovectin-7®	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

133 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center	Tucson	Arizona	United States	85724
2	University of Arkansas Cancer Research Center	Little Rock	Arkansas	United States	72205
3	Comprehensive Blood and Cancer Center	Bakersfield	California	United States	48202
4	University of California, San Francisco	San Francisco	California	United States	94115
5	University of Colorado Cancer Center	Denver	Colorado	United States	80010
6	Oncology Specialists, S.C.	Park Ridge	Illinois	United States	60068
7	Louisiana State University Medical Center	New Orleans	Louisiana	United States	70112
8	Hematology Oncology Associates of Baltimore	Baltimore	Maryland	United States	21236
9	North Memorial Health Care	Robbinsdale	Minnesota	United States	55422
10	Mayo Clinic	Rochester	Minnesota	United States	55905
11	The Melanoma Center of Saint Louis	Saint Louis	Missouri	United States	63131
12	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
13	Beth Israel Medical Center	New York	New York	United States	10003
14	Duke University Medical Center	Durham	North Carolina	United States	27710
15	MD Anderson Cancer Center	Houston	Texas	United States	77030
16	Cancer Care Alliance	Seattle	Washington	United States	98109