Clinical trial NCT00044356: Phase II Trial of Allovectin-7® for Metastatic Melanoma
Official title: A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Metastatic Melanoma
Malignant Melanoma
Skin Cancer
Keywords: Melanoma
Metastatic Melanoma
Malignant Melanoma
Skin Cancer
Tumor
Experimental Treatment
Clinical Trial
Gene Therapy
Gene Delivery
Gene Transfer
Immunotherapy
Cancer
Neoplasm
Lesion
Metastasis
Cancerous mole
Melanoma vaccine
Cancer research
Cancer cells
Allovectin-7®
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2002-08-28
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas Cancer Research Center
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Hematology Oncology Associates of Baltimore
state: Maryland
city: Robbinsdale
country: United States
facility: North Memorial Health Care
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: The Melanoma Center of Saint Louis
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Cancer Care Alliance
state: Washington
Study officials:
References: