Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006452
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2000-11-06
Brief Title:
Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I Trial to Evaluate Repetitive Intravenous Doses of Gadolinium-Texaphyrin as a Radiosensitizer in Patients With Glioblastoma Multiforme
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy
PURPOSE Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have supratentorial glioblastoma multiforme that has not been previously treated
PURPOSE Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have supratentorial glioblastoma multiforme that has not been previously treated
Detailed Description:
OBJECTIVES I Evaluate the toxic effects of gadolinium texaphyrin administered to patients receiving cranial radiotherapy for glioblastoma multiforme II Determine the maximum tolerated dose of this regimen in these patients III Determine the pharmacokinetic profile of this regimen in these patients IV Determine the biodistribution of gadolinium texaphyrin in both neoplastic tissue and normal brain parenchyma V Evaluate the effect and accumulation of this regimen in normal brain parenchyma and neoplastic tissue by following the change in enhancing volume and percent change in signal intensity over time
OUTLINE This is an open label multicenter study Arm I Patients receive radiotherapy once a day 5 days a week for 6 weeks Gadolinium texaphyrin IV is administered every other day within 2-5 hours prior to radiotherapy Patients are evaluated at 1 month and if no more than 1 of 3 patients experiences unacceptable toxicity 3 patients are entered on the imaging portion of the study Once arm I has successfully entered 3 patients with acceptable toxicity profiles and 3 patients in the imaging portion of the study patient enrollment begins for arm II Arm II Cohorts of 3-9 patients receive radiotherapy as in arm I and escalating doses of gadolinium texaphyrin IV administered within 2-5 hours prior to each radiation dose The maximum tolerated dose MTD of gadolinium texaphyrin is defined as the dose at which no more than one third of the patients experience dose limiting toxicity Arm III Patients experiencing dose limiting toxicity in arm II requiring dose reduction below predetermined once a day limit receive gadolinium every other day with radiotherapy as in arm II The MTD is defined as in arm II Arm IV An additional 3 patients are enrolled at the MTD and enter the imaging portion of the study Patients are followed for 1 month after final radiation therapy
PROJECTED ACCRUAL At least 18 patients will be accrued for this study within 6 months
OUTLINE This is an open label multicenter study Arm I Patients receive radiotherapy once a day 5 days a week for 6 weeks Gadolinium texaphyrin IV is administered every other day within 2-5 hours prior to radiotherapy Patients are evaluated at 1 month and if no more than 1 of 3 patients experiences unacceptable toxicity 3 patients are entered on the imaging portion of the study Once arm I has successfully entered 3 patients with acceptable toxicity profiles and 3 patients in the imaging portion of the study patient enrollment begins for arm II Arm II Cohorts of 3-9 patients receive radiotherapy as in arm I and escalating doses of gadolinium texaphyrin IV administered within 2-5 hours prior to each radiation dose The maximum tolerated dose MTD of gadolinium texaphyrin is defined as the dose at which no more than one third of the patients experience dose limiting toxicity Arm III Patients experiencing dose limiting toxicity in arm II requiring dose reduction below predetermined once a day limit receive gadolinium every other day with radiotherapy as in arm II The MTD is defined as in arm II Arm IV An additional 3 patients are enrolled at the MTD and enter the imaging portion of the study Patients are followed for 1 month after final radiation therapy
PROJECTED ACCRUAL At least 18 patients will be accrued for this study within 6 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-9712 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| NABTT-9712 | None | None | None |