A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
18 Years
N/A
Both
Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer
Trial Information
A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
VCL-1005-208
NCT ID:
NCT00044356
Start Date:
February 2001
Completion Date:
September 2004
Related Keywords:
- Melanoma
- Metastatic Melanoma
- Malignant Melanoma
- Skin Cancer
- 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®
- Skin Neoplasms
- Melanoma
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Beth Israel Medical Center | New York, New York 10003 |
| Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
| North Memorial Health Care | Robbinsdale, Minnesota 55422 |
| Louisiana State University Medical Center | Lafayette, Louisiana 70502-4016 |
| University of California, San Francisco | San Francisco, California 94143 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| University of Arkansas Cancer Research Center | Little Rock, Arkansas 72205 |
| Oncology Specialists, S.C. | Park Ridge, Illinois 60068 |
| Hematology Oncology Associates of Baltimore | Baltimore, Maryland 21236 |
| The Melanoma Center of Saint Louis | Saint Louis, Missouri 63131 |
| Cancer Care Alliance | Seattle, Washington 98109 |
