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Phase II Trial of Allovectin-7® for Metastatic Melanoma

Primary Purpose

Melanoma, Metastatic Melanoma, Malignant Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Allovectin-7®
Sponsored by
Vical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer, Tumor, Experimental Treatment, Clinical Trial, Gene Therapy, Gene Delivery, Gene Transfer, Immunotherapy, Cancer, Neoplasm, Lesion, Metastasis, Cancerous mole, Melanoma vaccine, Cancer research, Cancer cells, Allovectin-7®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arizona Cancer Center
  • University of Arkansas Cancer Research Center
  • Comprehensive Blood and Cancer Center
  • University of California, San Francisco
  • University of Colorado Cancer Center
  • Oncology Specialists, S.C.
  • Louisiana State University Medical Center
  • Hematology Oncology Associates of Baltimore
  • North Memorial Health Care
  • Mayo Clinic
  • The Melanoma Center of Saint Louis
  • Dartmouth-Hitchcock Medical Center
  • Beth Israel Medical Center
  • Duke University Medical Center
  • MD Anderson Cancer Center
  • Cancer Care Alliance

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 26, 2002
Last Updated
July 5, 2011
Sponsor
Vical
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1. Study Identification

Unique Protocol Identification Number
NCT00044356
Brief Title
Phase II Trial of Allovectin-7® for Metastatic Melanoma
Official Title
A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vical

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer
Keywords
Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer, Tumor, Experimental Treatment, Clinical Trial, Gene Therapy, Gene Delivery, Gene Transfer, Immunotherapy, Cancer, Neoplasm, Lesion, Metastasis, Cancerous mole, Melanoma vaccine, Cancer research, Cancer cells, Allovectin-7®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
Allovectin-7®

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas Cancer Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
48202
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Oncology Specialists, S.C.
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Louisiana State University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Hematology Oncology Associates of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
North Memorial Health Care
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Melanoma Center of Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.vical.com
Description
Related Info

Learn more about this trial

Phase II Trial of Allovectin-7® for Metastatic Melanoma

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