Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00003646|
Recruitment Status : Completed
First Posted : May 3, 2004
Last Update Posted : July 7, 2011
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 or disease||Intervention/treatment||Phase|
|Stage IV Melanoma Stage III Melanoma Recurrent Melanoma||Drug: allovectin-7||Phase 2|
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.
A total of 70 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||March 2002|
|Actual Study Completion Date :||May 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003646
|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|