Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003484
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
1999-11-01
Brief Title:
Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors
Sponsor:
Darell D Bigner MD PhD
Organization:
Duke University
Study Overview
Official Title:
Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy
Status:
COMPLETED
Status Verified Date:
2015-04
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 Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected
Detailed Description:
OBJECTIVES
Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the intracranial resection cavity in patients with newly diagnosed primary malignant brain tumors after surgery and radiotherapy
Determine objective therapeutic responses of these patients to this treatment
OUTLINE This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 I 131 MAb 81C6
Within 2-4 weeks after completion of external beam radiotherapy patients undergo surgical resection of the tumor or brain metastasis at which time an indwelling intracranial resection cavity catheter is placed A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter
Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 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 toxicities
After the MTD has been established patients in the phase II portion of the study receive therapy as in phase I
Beginning 4 weeks after the monoclonal antibody treatment patients begin chemotherapy Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression
Patients are followed initially at 4 weeks then every 6 weeks for 1 year
PROJECTED ACCRUAL A total of 41 patients will be accrued for this study
Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the intracranial resection cavity in patients with newly diagnosed primary malignant brain tumors after surgery and radiotherapy
Determine objective therapeutic responses of these patients to this treatment
OUTLINE This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 I 131 MAb 81C6
Within 2-4 weeks after completion of external beam radiotherapy patients undergo surgical resection of the tumor or brain metastasis at which time an indwelling intracranial resection cavity catheter is placed A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter
Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 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 toxicities
After the MTD has been established patients in the phase II portion of the study receive therapy as in phase I
Beginning 4 weeks after the monoclonal antibody treatment patients begin chemotherapy Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression
Patients are followed initially at 4 weeks then every 6 weeks for 1 year
PROJECTED ACCRUAL A total of 41 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000066522 | OTHER | National Cancer Institute Record Identifier | None |
| DUMC-1533-02-8R5ER | OTHER | None | None |
| DUMC-1533-01-8R4 | OTHER | None | None |
| DUMC-1373-97-9 | OTHER | None | None |
| DUMC-1408-98-9R1 | OTHER | None | None |
| DUMC-1533-00-8R3 | OTHER | None | None |
| DUMC-1570-99-9R2 | OTHER | None | None |
| DUMC-97107 | OTHER | None | None |
| 5P0NS20023 | OTHER_GRANT | None | None |
| NCI-G98-1472 | OTHER_GRANT | None | None |