Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002647
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Sponsor:
Medical College of Wisconsin
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Photodynamic Therapy For Childhood Brain Tumors A Phase I Study
Status:
UNKNOWN
Status Verified Date:
2009-06
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 Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors
PURPOSE This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors including astrocytoma ependymoma and medulloblastoma
PURPOSE This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors including astrocytoma ependymoma and medulloblastoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy
Determine the effect of this regimen on neurotoxicity clinical state imaging changes and survival of these patients
OUTLINE This is a dose-escalation study Patients are stratified according to tumor location posterior fossa tumors vs all other brain tumors
Patients receive benzoporphyrin monoacid ring A BPD-MA IV preoperatively Approximately 3 hours after BPD-MA administration patients undergo craniotomy with photoillumination of the tumor Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection
Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose MTD is determined The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Three additional patients are treated at the MTD
Patients are followed at 4 and 6 weeks every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A minimum of 24 patients will be accrued for this study within 3 years
Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy
Determine the effect of this regimen on neurotoxicity clinical state imaging changes and survival of these patients
OUTLINE This is a dose-escalation study Patients are stratified according to tumor location posterior fossa tumors vs all other brain tumors
Patients receive benzoporphyrin monoacid ring A BPD-MA IV preoperatively Approximately 3 hours after BPD-MA administration patients undergo craniotomy with photoillumination of the tumor Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection
Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose MTD is determined The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Three additional patients are treated at the MTD
Patients are followed at 4 and 6 weeks every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A minimum of 24 patients will be accrued for this study within 3 years
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-V95-0652 | None | None | None |
| MCW-7594 | None | None | None |
| MCW-CHW-511 | None | None | None |
| MCW-CHW-9411 | None | None | None |