Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004041
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
1999-12-10
Brief Title:
Gene Therapy in Treating Patients With Recurrent Malignant Gliomas
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase I Trial of Adenovirus-Mediated Wild-Type P53 Gene Therapy for Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2018-06
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 adenovirus p53 into a persons tumor may improve the bodys ability to fight cancer
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have recurrent malignant gliomas
PURPOSE Phase I trial to study the effectiveness of gene therapy in treating patients who have recurrent malignant gliomas
Detailed Description:
OBJECTIVES I Determine the biological effects at the molecular level of intratumoral administration of adenovirus p53 gene Ad-p53 in patients with malignant primary glioma II Determine the maximum tolerated dose of intratumoral Ad-p53 in these patients III Evaluate the qualitative and quantitative toxicity of intratumoral Ad-p53 in this patient population
OUTLINE This is a dose-escalation multicenter study Patients receive an initial intratumoral stereotactic injection of adenovirus p53 Ad-p53 over 10 minutes on day 1 In the absence of unacceptable toxicity resulting from this initial injection patients then undergo tumor resection and receive a series of 1-minute injections of Ad-p53 into the resected tumor cavity wall on day 4 Cohorts of 3-6 patients receive escalating doses of Ad-p53 If 2 of 3 or 3 of 6 patients experience dose limiting toxicity DLT at a particular dose level escalation ceases and the maximum tolerated dose is defined as the previous dose level Patients are followed closely for 12 weeks then every 2 weeks for 8 weeks then every 4 weeks for 8 weeks and then every 8 weeks until death
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
OUTLINE This is a dose-escalation multicenter study Patients receive an initial intratumoral stereotactic injection of adenovirus p53 Ad-p53 over 10 minutes on day 1 In the absence of unacceptable toxicity resulting from this initial injection patients then undergo tumor resection and receive a series of 1-minute injections of Ad-p53 into the resected tumor cavity wall on day 4 Cohorts of 3-6 patients receive escalating doses of Ad-p53 If 2 of 3 or 3 of 6 patients experience dose limiting toxicity DLT at a particular dose level escalation ceases and the maximum tolerated dose is defined as the previous dose level Patients are followed closely for 12 weeks then every 2 weeks for 8 weeks then every 4 weeks for 8 weeks and then every 8 weeks until death
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000066871 | REGISTRY | PDQ Physician Data Query | None |