Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005025
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-04-06
Brief Title:
Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer Fallopian Tube Cancer or Peritoneal Cancer
Sponsor:
John Stoddard Cancer Center at Iowa Methodist Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1584 | None | None | None |
| HGTRI-0105 | None | None | None |