Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004262
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2000-01-28
Brief Title:
Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN PCI -0120 AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy
Detailed Description:
PRIMARY OBJECTIVES
I Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery
II Compare the tumor normal brain and plasma concentrations of this drug regimen to 15 and 8 Tesla MRI images in this patient population
III Determine if the 8 Tesla images provide more data than the 15 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients
OUTLINE This is a dose escalation study
Within 5 weeks following surgery patients receive daily external beam radiotherapy five days a week for 5 weeks Within 2 weeks following completion of radiotherapy patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery
Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity
Patients are followed monthly for 3 months and then every 3 months for 5 years or until death
PROJECTED ACCRUAL Approximately 12-18 patients will be accrued for this study within 12-18 months
I Determine the frequency and grade of toxicity of gadolinium texaphyrin as a radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme undergoing stereotactic radiosurgery
II Compare the tumor normal brain and plasma concentrations of this drug regimen to 15 and 8 Tesla MRI images in this patient population
III Determine if the 8 Tesla images provide more data than the 15 Tesla images in terms of the radiosensitizing drug distribution in the tumor in these patients
OUTLINE This is a dose escalation study
Within 5 weeks following surgery patients receive daily external beam radiotherapy five days a week for 5 weeks Within 2 weeks following completion of radiotherapy patients receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic radiosurgery Patients undergoing surgical debulking of tumor prior to external beam radiotherapy receive gadolinium texaphyrin IV over 2 hours 3 hours prior to surgery in addition to the dose prior to stereotactic radiosurgery
Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity
Patients are followed monthly for 3 months and then every 3 months for 5 years or until death
PROJECTED ACCRUAL Approximately 12-18 patients will be accrued for this study within 12-18 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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| 99H0239 | None | None | None |
| CDR0000067517 | None | None | None |
| NCI-T99-0041 | None | None | None |
| OSU-9976 | None | None | None |
| OSU-99H0239 | None | None | None |