Phase II Trial of Allovectin-7® for Metastatic Melanoma

NCT ID: NCT00044356

Last Updated: 2011-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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Melanoma Metastatic Melanoma Malignant Melanoma Skin Cancer

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Allovectin-7®

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

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* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vical

INDUSTRY

Sponsor Role lead

Responsible Party

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Vical Incorporated

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

University of Arkansas Cancer Research Center

Little Rock, Arkansas, United States

Site Status

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

Oncology Specialists, S.C.

Park Ridge, Illinois, United States

Site Status

Louisiana State University Medical Center

New Orleans, Louisiana, United States

Site Status

Hematology Oncology Associates of Baltimore

Baltimore, Maryland, United States

Site Status

North Memorial Health Care

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

The Melanoma Center of Saint Louis

St Louis, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Cancer Care Alliance

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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VCL-1005-208

Identifier Type: -

Identifier Source: org_study_id

NCT00028444

Identifier Type: -

Identifier Source: nct_alias

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