Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032097
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
2002-03-08
Brief Title:
Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme
Status:
COMPLETED
Status Verified Date:
2004-01
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 motexafin gadolinium may make the tumor cells more sensitive to radiation therapy
PURPOSE Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain
PURPOSE Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain
Detailed Description:
OBJECTIVES
Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy
Determine the maximum tolerated doses of this drug on these 2 schedules in these patients
Determine the pharmacokinetic profile of this drug in these patients
Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients
Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients
Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter dose-escalation study of motexafin gadolinium PCI-0120 Patients are sequentially assigned to 1 of 2 treatment groups
Group I Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks
Group II Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy Patients undergo cranial radiotherapy as in group I
Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 month and then every 2 months thereafter
PROJECTED ACCRUAL Approximately 18-30 patients will be accrued for this study
Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy
Determine the maximum tolerated doses of this drug on these 2 schedules in these patients
Determine the pharmacokinetic profile of this drug in these patients
Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients
Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients
Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter dose-escalation study of motexafin gadolinium PCI-0120 Patients are sequentially assigned to 1 of 2 treatment groups
Group I Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks
Group II Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy Patients undergo cranial radiotherapy as in group I
Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 month and then every 2 months thereafter
PROJECTED ACCRUAL Approximately 18-30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-NABTT-2116 | None | None | None |
| NABTT-2116 | None | None | None |