Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003461
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
1999-11-01
Brief Title:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Study of At-Labeled Anti-Tenascin HumanMouse Chimeric Monoclonal Antibody 81C6 ch81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors
Status:
COMPLETED
Status Verified Date:
2013-02
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 Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells This may be effective treatment for primary or metastatic brain tumors
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors
Detailed Description:
OBJECTIVES
Determine the toxicity of monoclonal antibody MAb Astatine At 211 Antitenascin HumanMouse Chimeric 81C6 At 211 MAb 81C6 therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors
Identify objective therapeutic responses of these patients to this treatment
OUTLINE This is a dose escalation study
Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 At 211 MAb 81C6 via the intralesional catheter
Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6 The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity
Patients are followed initially at 4 weeks then at approximately 12 weeks at 24 weeks and then every 12 weeks for 1 year
PROJECTED ACCRUAL A total of 12-24 patients will be accrued for this study within 18-24 months
Determine the toxicity of monoclonal antibody MAb Astatine At 211 Antitenascin HumanMouse Chimeric 81C6 At 211 MAb 81C6 therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors
Identify objective therapeutic responses of these patients to this treatment
OUTLINE This is a dose escalation study
Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 At 211 MAb 81C6 via the intralesional catheter
Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6 The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity
Patients are followed initially at 4 weeks then at approximately 12 weeks at 24 weeks and then every 12 weeks for 1 year
PROJECTED ACCRUAL A total of 12-24 patients will be accrued for this study within 18-24 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 |
|---|---|---|---|
| DUMC-2237-01-12R4 | None | None | None |
| DUMC-0013-00-1R2 | None | None | None |
| DUMC-0036-99-1R1 | None | None | None |
| DUMC-060-98-1 | None | None | None |
| DUMC-2237-00-12R3 | None | None | None |
| DUMC-98007 | None | None | None |
| NCI-5P50NS20023 | None | None | None |
| NCI-G98-1462 | None | None | None |
| CDR0000066493 | None | None | None |