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Sponsored by: |
Vical |
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Information provided by: | Vical |
ClinicalTrials.gov Identifier: | NCT00003646 |
RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
Condition | Intervention | Phase |
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Stage IV Melanoma Stage III Melanoma Recurrent Melanoma |
Drug: allovectin-7 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma |
Study Start Date: | August 1998 |
OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent. II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.
PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.
PROJECTED ACCRUAL:
A total of 70 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
United States, Texas | |
Physician Reliance Network, Inc. | |
Dallas, Texas, United States, 75246 |
Study Chair: | Jennifer Fernandez | Vical |
Study ID Numbers: | CDR0000066735, VCL-1005-205 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003646 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult solid tumor body system/site cancer cancer melanoma recurrent melanoma |
skin tumor solid tumor stage III melanoma stage IV melanoma stage, melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Nevus |
Skin Neoplasms Recurrence Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |