Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004129
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-12-10
Brief Title:
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
Sponsor:
Center for Molecular Medicine
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Interstitial Colloidal 32P for the Treatment of Recurrent Malignant Central Nervous System Tumors and Primary Central Nervous System Tumors With Poor Prognostic Factors
Status:
UNKNOWN
Status Verified Date:
2008-04
Last Known Status:
RECRUITING
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 Radioactive drugs such as phosphorus 32 may be able to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme
PURPOSE This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme
Detailed Description:
OBJECTIVES
Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 C P32 in patients with recurrent or poor prognosis grade 4 astrocytoma
Determine the maximum tolerated dose of C P32 administered directly into the tumor of these patients
Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients
Determine the therapeutic response rate to the acceptable single and fractionated doses of C P32 in these patients
OUTLINE This is a dose-escalation study
Patients receive interstitial colloidal phosphorus P32 C P32 on day 0 Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients receive escalating doses of C P32 until the maximum tolerated dose MTD is determined The MTD is defined the dose at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed at 1 2 4 6 9 15 and 24 weeks
PROJECTED ACCRUAL A minimum of 12 patients will be accrued for this study
Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 C P32 in patients with recurrent or poor prognosis grade 4 astrocytoma
Determine the maximum tolerated dose of C P32 administered directly into the tumor of these patients
Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients
Determine the therapeutic response rate to the acceptable single and fractionated doses of C P32 in these patients
OUTLINE This is a dose-escalation study
Patients receive interstitial colloidal phosphorus P32 C P32 on day 0 Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients receive escalating doses of C P32 until the maximum tolerated dose MTD is determined The MTD is defined the dose at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed at 1 2 4 6 9 15 and 24 weeks
PROJECTED ACCRUAL A minimum of 12 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 |
|---|---|---|---|
| NCI-V99-1575 | None | None | None |
| CMM-2 | None | None | None |