- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00044356
Phase II Trial of Allovectin-7® for Metastatic Melanoma
July 5, 2011 updated by: Vical
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
133
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas Cancer Research Center
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California
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Bakersfield, California, United States, 48202
- Comprehensive Blood And Cancer Center
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San Francisco, California, United States, 94115
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80010
- University of Colorado Cancer Center
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Illinois
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Park Ridge, Illinois, United States, 60068
- Oncology Specialists, S.C.
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Louisiana State University Medical Center
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Maryland
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Baltimore, Maryland, United States, 21236
- Hematology Oncology Associates of Baltimore
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Minnesota
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Robbinsdale, Minnesota, United States, 55422
- North Memorial Health Care
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, United States, 63131
- The Melanoma Center of Saint Louis
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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New York
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New York, New York, United States, 10003
- Beth Israel Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98109
- Cancer Care Alliance
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Primary Completion (Actual)
August 1, 2004
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
August 26, 2002
First Submitted That Met QC Criteria
August 27, 2002
First Posted (Estimate)
August 28, 2002
Study Record Updates
Last Update Posted (Estimate)
July 7, 2011
Last Update Submitted That Met QC Criteria
July 5, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VCL-1005-208
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma
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H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.RecruitingMetastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous MelanomaUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Mucosal Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA MelanomaUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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MelanomaPRO, RussiaRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, OcularRussian Federation
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National Cancer Institute (NCI)CompletedStage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC MelanomaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkTerminatedRecurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...United States
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Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA MelanomaUnited States
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BiocadRecruitingMelanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma Metastatic | Melanoma Unresectable | Melanoma AdvancedIndia, Russian Federation, Belarus
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
Clinical Trials on Allovectin-7®
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VicalCompletedHead and Neck Cancer | Head and Neck Neoplasms | Carcinoma of the Head and Neck | Squamous Cell Carcinoma of the Oral Cavity or OropharynxUnited States
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VicalCompletedRecurrent Melanoma | Stage IV Melanoma | Stage III MelanomaUnited States
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VicalCompletedRecurrent Melanoma | Stage IV Melanoma | Stage III MelanomaUnited States
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VicalCompletedMetastatic MelanomaUnited States, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, Switzerland, Turkey
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Ethicon Endo-SurgeryCompletedBenign Disease Where Total Hysterectomy is IndicatedUnited States, Netherlands, United Kingdom
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Procter and GambleCompletedDental Plaque | Dental Gingivitis
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Ethicon Endo-SurgeryCompletedBenign or Malignant Disease Indicated for ColectomyUnited States, Belgium, United Kingdom
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Antalya Training and Research HospitalCompletedCesarean Section ComplicationsTurkey
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University of FloridaIsagenix International LLCCompleted
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Kang Stem Biotech Co., Ltd.RecruitingSafety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD) (smart(FURIN))Dermatitis, AtopicKorea, Republic of