Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003876
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
Sponsor:
Barrett Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Concurrent Multi-modality Treatment for Patients With Relapsed Malignant Glioma Using Permanent I-125 Interstitial Seeds and Dose Escalation of Gliadel 385 Carmustine BCNU Polymer Wafers
Status:
COMPLETED
Status Verified Date:
2001-05
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 Internal radiation uses high-energy radiation to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery
PURPOSE Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma
PURPOSE Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma
Detailed Description:
OBJECTIVES I Assess the toxic effects of concurrent permanent iodine I 125 interstitial seed implants and polifeprosan 20 with carmustine implant Gliadel wafers in patients with recurrent or refractory malignant glioma II Assess preliminary efficacy of this regimen in terms of progression free survival and overall survival of these patients III Assess impact of this regimen on the quality of life and performance status of these patients IV Assess site of tumor progression following this regimen in these patients V Assess the relationship between progression free survival and the MIB-1 proliferative index of the resected malignant glioma
OUTLINE This is a dose escalation study Patients undergo craniotomy with the intent to obtain a complete resection of enhancing tumor Following maximum tumor removal iodine I 125 seeds and up to 8 polifeprosan 20 with carmustine implants Gliadel wafers are implanted into the resected tumor cavity Cohorts of 6 patients each receive increasing numbers of Gliadel wafers placed into the tumor cavity Quality of life is assessed at baseline then every 3 months and at tumor progression Patients are followed monthly until death
PROJECTED ACCRUAL A total of 12-18 patients will be accrued for this study within 18 months
OUTLINE This is a dose escalation study Patients undergo craniotomy with the intent to obtain a complete resection of enhancing tumor Following maximum tumor removal iodine I 125 seeds and up to 8 polifeprosan 20 with carmustine implants Gliadel wafers are implanted into the resected tumor cavity Cohorts of 6 patients each receive increasing numbers of Gliadel wafers placed into the tumor cavity Quality of life is assessed at baseline then every 3 months and at tumor progression Patients are followed monthly until death
PROJECTED ACCRUAL A total of 12-18 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| CDR0000067042 | REGISTRY | None | None |
| UCMC-55853 | None | None | None |
| NCI-V99-1543 | Registry Identifier | PDQ Physician Data Query | None |