Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003478
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
1999-11-01
Brief Title:
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase I Study of Intra-Tumoral Radiolabeled Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary 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 Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances such as radioactive iodine to them without harming normal cells
PURPOSE This randomized phase III trial is studying the side effects best way to give and best dose of radiolabeled monoclonal antibody and to see how well it works in treating patients with primary brain tumors
PURPOSE This randomized phase III trial is studying the side effects best way to give and best dose of radiolabeled monoclonal antibody and to see how well it works in treating patients with primary brain tumors
Detailed Description:
OBJECTIVES
Determine which one of two delivery techniques bolus injection versus microinfusion provides the greater distribution volume of iodine I 131 antitenascin monoclonal antibody 81C6 I 131 MAb 81C6 administered intratumorally in patients with newly diagnosed or recurrent malignant primary brain tumors
Determine the maximum tolerated dose of I 131 MAb 81C6 delivered intratumorally in these patients
Evaluate the efficacy of I 131 MAB 81C6 delivered intratumorally in these patients
OUTLINE This is a randomized dose-escalation study
Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 I 131 MAb 81C6 by one of two delivery techniques first then crossover to receive the antibody by the other technique 3 days later Each patient then receives a therapeutic dose by the most efficient method Both methods are delivered via a stereotactically-placed intralesional catheter
Arm I Bolus injection method
Arm II Microinfusion delivery method Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 with dose escalation occurring separately for each arm After 10 patients are enrolled and the best method of administration is determined all subsequent patients receive I 131 MAb 81C6 by that method and the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more the 2 of 6 patients experience dose-limiting toxicity
Patients with newly diagnosed tumors for which no effective conventional therapy exists such as malignant glial tumors are treated with external beam radiotherapy within 4 months after I 131 MAb 81C6 infusion Patients with recurrent tumors receive no other therapy unless tumor progresses
Patients are followed at 4 8 16 and 24 weeks and then every 12 weeks for one year
PROJECTED ACCRUAL At least 10 patients will be accrued for this study within 1 year
Determine which one of two delivery techniques bolus injection versus microinfusion provides the greater distribution volume of iodine I 131 antitenascin monoclonal antibody 81C6 I 131 MAb 81C6 administered intratumorally in patients with newly diagnosed or recurrent malignant primary brain tumors
Determine the maximum tolerated dose of I 131 MAb 81C6 delivered intratumorally in these patients
Evaluate the efficacy of I 131 MAB 81C6 delivered intratumorally in these patients
OUTLINE This is a randomized dose-escalation study
Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 I 131 MAb 81C6 by one of two delivery techniques first then crossover to receive the antibody by the other technique 3 days later Each patient then receives a therapeutic dose by the most efficient method Both methods are delivered via a stereotactically-placed intralesional catheter
Arm I Bolus injection method
Arm II Microinfusion delivery method Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 with dose escalation occurring separately for each arm After 10 patients are enrolled and the best method of administration is determined all subsequent patients receive I 131 MAb 81C6 by that method and the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more the 2 of 6 patients experience dose-limiting toxicity
Patients with newly diagnosed tumors for which no effective conventional therapy exists such as malignant glial tumors are treated with external beam radiotherapy within 4 months after I 131 MAb 81C6 infusion Patients with recurrent tumors receive no other therapy unless tumor progresses
Patients are followed at 4 8 16 and 24 weeks and then every 12 weeks for one year
PROJECTED ACCRUAL At least 10 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000066515 | OTHER | NCI | None |
| DUMC-1529-01-8R4 | None | None | None |
| DUMC-1363-97-9 | None | None | None |
| DUMC-1409-98-9R1 | None | None | None |
| DUMC-1529-00-8R3 | None | None | None |
| DUMC-1630-99-9R2 | None | None | None |
| DUMC-97112 | None | None | None |
| NCI-5950NS20023 | None | None | None |
| NCI-G98-1471 | None | None | None |