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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.
 
ClinicalTrials.gov Identifier: NCT00044356
Recruitment Status : Completed
First Posted : August 28, 2002
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
Vical

Tracking Information
First Submitted Date  ICMJE August 26, 2002
First Posted Date  ICMJE August 28, 2002
Last Update Posted Date July 7, 2011
Study Start Date  ICMJE February 2001
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial of Allovectin-7® for Metastatic Melanoma
Official Title  ICMJE A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Metastatic Melanoma
  • Malignant Melanoma
  • Skin Cancer
Intervention  ICMJE Genetic: Allovectin-7®
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July¬†5,¬†2011)
133
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00044356
Other Study ID Numbers  ICMJE VCL-1005-208
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
Study Sponsor  ICMJE Vical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vical
Verification Date July 2011

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