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Phase II Trial of Allovectin-7® for Metastatic Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044356
First Posted: August 28, 2002
Last Update Posted: July 7, 2011
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.
Information provided by:
Vical
August 26, 2002
August 28, 2002
July 7, 2011
February 2001
August 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00044356 on ClinicalTrials.gov Archive Site
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Phase II Trial of Allovectin-7® for Metastatic Melanoma
A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
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.
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.
Interventional
Phase 2
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Melanoma
  • Metastatic Melanoma
  • Malignant Melanoma
  • Skin Cancer
Genetic: Allovectin-7®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
September 2004
August 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00044356
VCL-1005-208
No
Not Provided
Not Provided
Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
Vical
Not Provided
Not Provided
Vical
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP