Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT00005025|
Recruitment Status : Unknown
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 5, 2003
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Biological: herpes simplex thymidine kinase Drug: ganciclovir||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer|
|Study Start Date :||June 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005025
|United States, Iowa|
|Human Gene Therapy Research Institute|
|Des Moines, Iowa, United States, 50309|
|Study Chair:||Charles Joseph Link, MD||John Stoddard Cancer Center at Iowa Methodist Medical Center|