Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004080
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
1999-12-10
Brief Title:
Gene Therapy in Treating Patients With Recurrent or Progressive Brain Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Assessment of the Safety and Transduction Efficiency of SCH58500 An Adenoviral Vector p53 Delivery System to Patients With Recurrent Malignant Brain Tumors
Status:
COMPLETED
Status Verified Date:
2001-08
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 p53 into a persons brain cells may improve the bodys ability to fight cancer
PURPOSE Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in treating patients who have recurrent or progressive glioblastoma multiforme anaplastic astrocytoma or anaplastic mixed glioma that can be removed during surgery
PURPOSE Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in treating patients who have recurrent or progressive glioblastoma multiforme anaplastic astrocytoma or anaplastic mixed glioma that can be removed during surgery
Detailed Description:
OBJECTIVES I Estimate the efficiency of tumor cell transduction with adenovirus p53 delivered stereotactically to patients with recurrent or progressive resectable glioblastoma multiforme anaplastic astrocytoma or anaplastic mixed glioma II Determine the maximum tolerated dose of adenovirus p53 delivered stereotactically and with craniotomy in these patients III Correlate analysis of predelivery tumor specimen p53 gene status with postdelivery p53 gene status clinical status and tumor staging in these patients treated with this regimen IV Correlate analysis of postdelivery tumor specimen p53 gene status and local tumor immune response with postdelivery clinical status and tumor imaging in these patients treated with this regimen
OUTLINE This is a dose escalation multicenter study Patients receive SCH-58500 via stereotactic injection into the tumor followed 24-72 hours later by craniotomy Patients undergo tumor resection followed by injection of SCH-58500 into the tumor bed during craniotomy Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum tolerated dose MTD is determined The MTD is defined as the dose immediately preceding that at which 3 of 3-6 patients experience dose limiting toxicity Patients are followed at day 28 then every 2 months for 1 year and then annually thereafter until another therapy is begun or disease progression is documented
PROJECTED ACCRUAL A total of 21-42 patients will be accrued for this study over 14-27 months
OUTLINE This is a dose escalation multicenter study Patients receive SCH-58500 via stereotactic injection into the tumor followed 24-72 hours later by craniotomy Patients undergo tumor resection followed by injection of SCH-58500 into the tumor bed during craniotomy Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum tolerated dose MTD is determined The MTD is defined as the dose immediately preceding that at which 3 of 3-6 patients experience dose limiting toxicity Patients are followed at day 28 then every 2 months for 1 year and then annually thereafter until another therapy is begun or disease progression is documented
PROJECTED ACCRUAL A total of 21-42 patients will be accrued for this study over 14-27 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 |
|---|---|---|---|
| JHOC-NABTT-9703 | None | None | None |
| NABTT-9703 | None | None | None |