NCT00044356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2001

Typical duration for phase_2

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

3.5 years

First QC Date

August 26, 2002

Last Update Submit

July 5, 2011

Conditions

MelanomaMetastatic MelanomaMalignant MelanomaSkin Cancer

Keywords

MelanomaMetastatic MelanomaMalignant MelanomaSkin CancerTumorExperimental TreatmentClinical TrialGene TherapyGene DeliveryGene TransferImmunotherapyCancerNeoplasmLesionMetastasisCancerous moleMelanoma vaccineCancer researchCancer cellsAllovectin-7®

Interventions

Allovectin-7®GENETIC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (16)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas Cancer Research Center

Little Rock, Arkansas, 72205, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 48202, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Oncology Specialists, S.C.

Park Ridge, Illinois, 60068, United States

Location

Louisiana State University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Hematology Oncology Associates of Baltimore

Baltimore, Maryland, 21236, United States

Location

North Memorial Health Care

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Melanoma Center of Saint Louis

St Louis, Missouri, 63131, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

MelanomaSkin NeoplasmsNeoplasmsNeoplasm Metastasis

Interventions

Allovectin-7

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 26, 2002

First Posted

August 28, 2002

Study Start

February 1, 2001

Primary Completion

August 1, 2004

Study Completion

September 1, 2004

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

US(16)