Trial record 8 of 1483 for:    "Melanoma"

Phase II Trial of Allovectin-7® for Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
Vical
ClinicalTrials.gov Identifier:
NCT00044356
First received: August 26, 2002
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Melanoma
Metastatic Melanoma
Malignant Melanoma
Skin Cancer
Genetic: Allovectin-7®
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Vical:

Enrollment: 133
Study Start Date: February 2001
Study Completion Date: September 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044356

Locations
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
Vical
  More Information

Additional Information:
No publications provided

Responsible Party: Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
ClinicalTrials.gov Identifier: NCT00044356     History of Changes
Obsolete Identifiers: NCT00028444
Other Study ID Numbers: VCL-1005-208
Study First Received: August 26, 2002
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vical:
Melanoma
Metastatic Melanoma
Malignant Melanoma
Melanoma vaccine
Skin Cancer
Tumor
Experimental Treatment
Clinical Trial
Gene Therapy
Gene Delivery
Gene Transfer
Immunotherapy
Cancer
Neoplasm
Lesion
Metastasis
Cancerous mole
Cancer research
Cancer cells
Allovectin-7®

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 29, 2014