Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002824
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
1999-11-01
Brief Title:
Gene Therapy in Treating Patients With Primary Brain Tumors
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A PHASE I TRIAL OF HSV-TK ADENOVIRUS GENE THERAPY FOR PRIMARY BRAIN TUMORS
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
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 Inserting the gene for herpes virus into a persons cells may improve the bodys ability to fight cancer or make the cancer more sensitive to chemotherapy using antiviral drugs such as ganciclovir
PURPOSE Phase I trial to study the effectivenesss of gene therapy in treating patients with primary brain tumors
PURPOSE Phase I trial to study the effectivenesss of gene therapy in treating patients with primary brain tumors
Detailed Description:
OBJECTIVES I Assess the response to a stereotactically administered recombinant adenovirus vector carrying the herpes simplex virus thymidine kinase gene H5010RSVTK followed by intravenous ganciclovir in patients with recurrent malignant glioma II Estimate the maximum tolerated dose of H5010RSVTK in these patients III Describe the toxic effects of H5010RSVTK IV Assess the efficiency of gene transfer and duration of transgene expression in these patients V Assess quantitative and qualitative glucose metabolic activity of tumoral sites by positron emission tomography VI Analyze the immunologic response to adenovirus transduction in these patients VII Determine the benefit and toxicity of multiple doses of H5010RSVTK in patients with resectable tumors
OUTLINE This is a dose-finding study All patients receive stereotactically injected H5010RSVTK a recombinant adenovirus vector containing the herpes simplex virus thymidine kinase gene Cohorts of 3-6 patients receive escalating doses of H5010RSVTK until the maximum tolerated dose is reached Ganciclovir is then given on the third post-injection day Patients with unresectable tumors receive ganciclovir for 14 consecutive days Patients with resectable tumors receive ganciclovir for 7 consecutive days before undergoing craniotomy with optimal debulking and injection of a second dose of the adenovirus vector followed by ganciclovir for 14 more days Patients are followed monthly for survival
PROJECTED ACCRUAL A total of 18 patients 9 with resectable tumors and 9 with unresectable tumors will be entered over 3 years
OUTLINE This is a dose-finding study All patients receive stereotactically injected H5010RSVTK a recombinant adenovirus vector containing the herpes simplex virus thymidine kinase gene Cohorts of 3-6 patients receive escalating doses of H5010RSVTK until the maximum tolerated dose is reached Ganciclovir is then given on the third post-injection day Patients with unresectable tumors receive ganciclovir for 14 consecutive days Patients with resectable tumors receive ganciclovir for 7 consecutive days before undergoing craniotomy with optimal debulking and injection of a second dose of the adenovirus vector followed by ganciclovir for 14 more days Patients are followed monthly for survival
PROJECTED ACCRUAL A total of 18 patients 9 with resectable tumors and 9 with unresectable tumors will be entered over 3 years
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 |
|---|---|---|---|
| UPCC-3394 | None | None | None |
| NCI-H96-0976 | None | None | None |