Phase II Trial of Allovectin-7® for Metastatic Melanoma
This study has been completed.
Sponsor:
Vical
Information provided by:
Vical
ClinicalTrials.gov Identifier:
NCT00044356
First received: August 26, 2002
Last updated: July 5, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Metastatic Melanoma Malignant Melanoma Skin Cancer |
Genetic: Allovectin-7® |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma |
Resource links provided by NLM:
Further study details as provided by Vical:
| Enrollment: | 133 |
| Study Start Date: | February 2001 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044356
Locations
| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| University of Arkansas Cancer Research Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Comprehensive Blood and Cancer Center | |
| Bakersfield, California, United States, 48202 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Illinois | |
| Oncology Specialists, S.C. | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Louisiana | |
| Louisiana State University Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Hematology Oncology Associates of Baltimore | |
| Baltimore, Maryland, United States, 21236 | |
| United States, Minnesota | |
| North Memorial Health Care | |
| Robbinsdale, Minnesota, United States, 55422 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| The Melanoma Center of Saint Louis | |
| Saint Louis, Missouri, United States, 63131 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
Sponsors and Collaborators
Vical
More Information
Additional Information:
No publications provided
| Responsible Party: | Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated |
| ClinicalTrials.gov Identifier: | NCT00044356 History of Changes |
| Obsolete Identifiers: | NCT00028444 |
| Other Study ID Numbers: | VCL-1005-208 |
| Study First Received: | August 26, 2002 |
| Last Updated: | July 5, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Vical:
|
Melanoma Metastatic Melanoma Malignant Melanoma Melanoma vaccine Skin Cancer Tumor Experimental Treatment Clinical Trial Gene Therapy Gene Delivery |
Gene Transfer Immunotherapy Cancer Neoplasm Lesion Metastasis Cancerous mole Cancer research Cancer cells Allovectin-7® |
Additional relevant MeSH terms:
|
Melanoma Nevi and Melanomas Skin Neoplasms Neoplasms by Site Neoplasms Skin Diseases |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013