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A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating women who have refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
OBJECTIVES: * Determine the efficacy and safety of in vivo gene therapy with herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) followed by ganciclovir in women with refractory or relapsed ovarian epithelial adenocarcinoma, fallopian tube cancer, or peritoneal cancer. * Determine any development of systemic immunity to this regimen or tumor in these patients. * Determine the toxic effects of intraperitoneal HSVtk VPC in these patients. OUTLINE: All patients receive an intraperitoneal catheter prior to infusion. Patients receive herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) IP over 15-60 minutes on day 0, followed by ganciclovir IV 2 times daily on days 28-41. Treatment repeats for up to 3 courses in patients with stable or responsive disease. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 14-20 patients will be accrued for this study within 18-24 months.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Human Gene Therapy Research Institute
Des Moines, Iowa, United States
Start Date
June 1, 2000
Last Updated
November 6, 2013
herpes simplex thymidine kinase
BIOLOGICAL
ganciclovir
DRUG
Lead Sponsor
John Stoddard Cancer Center at Iowa Methodist Medical Center
NCT04550494
NCT05039801
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