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| ID | Type | Description | Link |
|---|---|---|---|
| PEREGRINE-TNT9802 | |||
| MUSC-7993 | |||
| PEREGRINE-BB-IND-7344 | |||
| TCLONE-BB-IND-7344 | |||
| TCLONE-TNT9802 | |||
| NCI-G99-1560 |
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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.
OBJECTIVES:
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-1/B 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional surgery | Procedure | |||
| iodine I 131 monoclonal antibody TNT-1/B | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma (AA)
MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm^3
At least 5 days since prior surgical debulking
No planned resection of newly diagnosed GBM before or during study
No bilateral noncontiguous gadolinium enhancing tumors
No satellite lesions greater than 1.5 cm from anticipated location of interstitial catheter tip
No more than 2 satellite lesions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Terrence G. Chew, MD | Peregrine Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28207-1830 | United States | ||
| Temple University |
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| Philadelphia |
| Pennsylvania |
| 19140 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| C576180 | 131I-chimeric TNT-1-B monoclonal antibody |
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