Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004017
Status:
COMPLETED
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma
Sponsor:
Peregrine Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Open-Label Non-Randomized Multicenter Study of Interstitial 131I-chTNT-1B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2003-03
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 tumor-killing substances to them without harming normal cells This may be an effective treatment for some types of brain tumors
PURPOSE Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma
PURPOSE Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma
Detailed Description:
OBJECTIVES
Determine the median time to disease progression in patients with newly diagnosed unresectable glioblastoma multiforme GBM recurrent GBM or recurrent anaplastic astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1B
Determine the median survival time of these patients treated with this regimen
Determine the safety of this regimen in terms of neurotoxicity renal hepatic hematologic and biochemical profiles in these patients
Confirm the maximum tolerated dose of this regimen in these patients
Optimize the drug delivery of this regimen in these patients
Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of study drug
OUTLINE This is a multicenter study
Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed One day later patients receive iodine I 131 monoclonal antibody TNT-1B interstitially over approximately 24 hours At selected centers up to 3 additional groups of 3 patients each will receive study drug up to 48 hours Catheters are removed 1 day after completion of the infusion A gadolinium enhanced MRI is performed during week 8 Patients with partial response minimal response or stable disease repeat the above treatments during week 9 Patients with complete response progressive disease or unacceptable toxicity receive no additional treatment
Patients are followed every month until disease progression All patients regardless of disease progression or retreatment are followed at 36 weeks
PROJECTED ACCRUAL A total of 60 patients 20 patients with newly diagnosed unresectable glioblastoma multiforme GBM 20 patients with recurrent GBM and 20 patients with recurrent anaplastic astrocytoma will be accrued for this study
Determine the median time to disease progression in patients with newly diagnosed unresectable glioblastoma multiforme GBM recurrent GBM or recurrent anaplastic astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1B
Determine the median survival time of these patients treated with this regimen
Determine the safety of this regimen in terms of neurotoxicity renal hepatic hematologic and biochemical profiles in these patients
Confirm the maximum tolerated dose of this regimen in these patients
Optimize the drug delivery of this regimen in these patients
Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of study drug
OUTLINE This is a multicenter study
Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed One day later patients receive iodine I 131 monoclonal antibody TNT-1B interstitially over approximately 24 hours At selected centers up to 3 additional groups of 3 patients each will receive study drug up to 48 hours Catheters are removed 1 day after completion of the infusion A gadolinium enhanced MRI is performed during week 8 Patients with partial response minimal response or stable disease repeat the above treatments during week 9 Patients with complete response progressive disease or unacceptable toxicity receive no additional treatment
Patients are followed every month until disease progression All patients regardless of disease progression or retreatment are followed at 36 weeks
PROJECTED ACCRUAL A total of 60 patients 20 patients with newly diagnosed unresectable glioblastoma multiforme GBM 20 patients with recurrent GBM and 20 patients with recurrent anaplastic astrocytoma will be accrued for this study
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-G99-1560 | None | None | None |
| PEREGRINE-TNT9802 | None | None | None |
| MUSC-7993 | None | None | None |
| PEREGRINE-BB-IND-7344 | None | None | None |
| TCLONE-BB-IND-7344 | None | None | None |
| TCLONE-TNT9802 | None | None | None |