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Phase II Trial of Allovectin-7® for Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044356
Recruitment Status : Completed
First Posted : August 28, 2002
Last Update Posted : July 7, 2011
Information provided by:

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2001
Actual Primary Completion Date : August 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044356

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United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas Cancer Research Center
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 48202
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Illinois
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, Louisiana
Louisiana State University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Hematology Oncology Associates of Baltimore
Baltimore, Maryland, United States, 21236
United States, Minnesota
North Memorial Health Care
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
The Melanoma Center of Saint Louis
Saint Louis, Missouri, United States, 63131
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Additional Information:
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Responsible Party: Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated Identifier: NCT00044356    
Obsolete Identifiers: NCT00028444
Other Study ID Numbers: VCL-1005-208
First Posted: August 28, 2002    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011
Keywords provided by Vical:
Metastatic Melanoma
Malignant Melanoma
Skin Cancer
Experimental Treatment
Clinical Trial
Gene Therapy
Gene Delivery
Gene Transfer
Cancerous mole
Melanoma vaccine
Cancer research
Cancer cells
Additional relevant MeSH terms:
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Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases