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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-03133 | Other Identifier | Memorial Sloan Kettering Cancer Center |
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Corporate business decision. No safety or efficacy concerns.
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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
The purpose of this study is to test the feasibility and toxicity of administering intrathecal immunotherapy for patients with central nervous system/leptomeningeal (CNS/LM) malignancies.
This is a phase I study, where the purpose is to find a safe dose of a new medicine called antibody 8H9. Antibodies are made by the body to fight infections and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiolabeled Monoclonal Antibody Therapy | Experimental | This is a Phase I trial designed to evaluate the Maximally Tolerated Dose (MTD) of intrathecal 131I-8H9. In order to find the MTD, a dose escalation scheme will be employed with patients entering in cohorts of 3 at each dose level from 10 mCi to 60 mCi and a cohort of 6 at each dose level from 70 mCi to 100 mCi. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine I 131 MOAB 8H9 | Drug | Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients that have treatment related toxicities | Assessment of patient with treatment related toxicities | 2 years |
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Subject Inclusion Criteria:
Subject Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Kramer, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36371226 | Derived | Kramer K, Pandit-Taskar N, Kushner BH, Zanzonico P, Humm JL, Tomlinson U, Donzelli M, Wolden SL, Haque S, Dunkel I, Souweidane MM, Greenfield JP, Tickoo S, Lewis JS, Lyashchenko SK, Carrasquillo JA, Chu B, Horan C, Larson SM, Cheung NV, Modak S. Phase 1 study of intraventricular 131I-omburtamab targeting B7H3 (CD276)-expressing CNS malignancies. J Hematol Oncol. 2022 Nov 12;15(1):165. doi: 10.1186/s13045-022-01383-4. | |
| 33047248 |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| D055756 | Meningeal Carcinomatosis |
| D001932 | Brain Neoplasms |
| D008527 | Medulloblastoma |
| D012516 | Osteosarcoma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018335 | Rhabdoid Tumor |
| D058405 | Desmoplastic Small Round Cell Tumor |
| D012208 | Rhabdomyosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000633765 | omburtamab I-131 |
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| Iodine I 131 MOAB 8H9 | Drug | The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle. |
|
| Derived |
| Yerrabelli RS, He P, Fung EK, Kramer K, Zanzonico PB, Humm JL, Guo H, Pandit-Taskar N, Larson SM, Cheung NV. IntraOmmaya compartmental radioimmunotherapy using 131I-omburtamab-pharmacokinetic modeling to optimize therapeutic index. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1166-1177. doi: 10.1007/s00259-020-05050-z. Epub 2020 Oct 13. |
| D018242 |
| Neuroectodermal Tumors, Primitive |
| 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 |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D008577 | Meningeal Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D005910 | Glioma |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |