Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003788
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Surgery Radiation Therapy and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
Sponsor:
Colorado Health Foundation
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Prospective Clinical Trials in the Use of Photodynamic Therapy PDT for the Treatment of Malignant Supratentorial Brain Tumors
Status:
UNKNOWN
Status Verified Date:
2003-09
Last Known Status:
ACTIVE_NOT_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 drugs that make cancer cells more sensitive to light to kill tumor cells It is not yet known if the addition of photodynamic therapy to combined therapy with surgery radiation therapy and chemotherapy is more effective than combined therapy alone for supratentorial gliomas
PURPOSE Randomized phase III trial to study the effectiveness of surgery radiation therapy and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas
PURPOSE Randomized phase III trial to study the effectiveness of surgery radiation therapy and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas
Detailed Description:
OBJECTIVES
Determine whether the addition of photodynamic therapy to standard brain tumor care surgical resection postoperative radiotherapy and chemotherapy will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant supratentorial gliomas
Compare the effect of high or low light dose photodynamic therapy on survival of patients with recurrent malignant supratentorial gliomas
OUTLINE This is a randomized multicenter two part study Patients are stratified according to clinical center
Newly diagnosed patients Study 1
Patients are randomized to receive either high light dose photodynamic therapy arm I or no photodynamic therapy arm II
Arm I Patients receive porfimer sodium Photofrin IV one day prior to surgery Craniotomy and tumor resection are performed Upon completion of resection patients undergo intracavitary photoillumination with a high light dose
Arm II Craniotomy and tumor resection are performed Postoperatively all patients receive external beam radiotherapy 5 days per week for 5-6 weeks After completing radiotherapy patients receive nitrosourea carmustine or lomustine chemotherapy
Recurrent tumor patients Study 2
Patients receive Photofrin IV one day prior to surgery Craniotomy and tumor resection are performed
Arm I Patients receive high dose light therapy during surgery
Arm II Patients receive low dose light therapy during surgery Patients receive chemotherapy with procarbazine for 28 days beginning 2-4 weeks after surgery Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity
Patients are followed on both studies at 4 weeks postsurgery then every 3 months until death or for 1 year after study closure
PROJECTED ACCRUAL A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years Study 1 A maximum of 120 patients with recurrent disease will be accrued within 45 years Study 2
Determine whether the addition of photodynamic therapy to standard brain tumor care surgical resection postoperative radiotherapy and chemotherapy will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant supratentorial gliomas
Compare the effect of high or low light dose photodynamic therapy on survival of patients with recurrent malignant supratentorial gliomas
OUTLINE This is a randomized multicenter two part study Patients are stratified according to clinical center
Newly diagnosed patients Study 1
Patients are randomized to receive either high light dose photodynamic therapy arm I or no photodynamic therapy arm II
Arm I Patients receive porfimer sodium Photofrin IV one day prior to surgery Craniotomy and tumor resection are performed Upon completion of resection patients undergo intracavitary photoillumination with a high light dose
Arm II Craniotomy and tumor resection are performed Postoperatively all patients receive external beam radiotherapy 5 days per week for 5-6 weeks After completing radiotherapy patients receive nitrosourea carmustine or lomustine chemotherapy
Recurrent tumor patients Study 2
Patients receive Photofrin IV one day prior to surgery Craniotomy and tumor resection are performed
Arm I Patients receive high dose light therapy during surgery
Arm II Patients receive low dose light therapy during surgery Patients receive chemotherapy with procarbazine for 28 days beginning 2-4 weeks after surgery Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity
Patients are followed on both studies at 4 weeks postsurgery then every 3 months until death or for 1 year after study closure
PROJECTED ACCRUAL A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years Study 1 A maximum of 120 patients with recurrent disease will be accrued within 45 years Study 2
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-V99-1525 | None | None | None |
| HEALTHONE-43892 | None | None | None |
| HEALTHONE-1A | None | None | None |
| HEALTHONE-CA43892 | None | None | None |
| RPCI-DS-9802 | None | None | None |