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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000065607 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-G97-1267 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection.
Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).
Patients are followed weekly for 4 weeks.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iodine I 131 monoclonal antibody 3F8 | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy expressing GD2, including, but not limited to:
Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
Prior measurable human anti-mouse monoclonal antibody titer allowed
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Kramer, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18048828 | Result | Kramer K, Humm JL, Souweidane MM, Zanzonico PB, Dunkel IJ, Gerald WL, Khakoo Y, Yeh SD, Yeung HW, Finn RD, Wolden SL, Larson SM, Cheung NK. Phase I study of targeted radioimmunotherapy for leptomeningeal cancers using intra-Ommaya 131-I-3F8. J Clin Oncol. 2007 Dec 1;25(34):5465-70. doi: 10.1200/JCO.2007.11.1807. |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D000098943 | Uveal Melanoma |
| D008175 | Lung Neoplasms |
| D008545 | Melanoma |
| D009447 | Neuroblastoma |
| D012175 | Retinoblastoma |
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| D055752 | Small Cell Lung Carcinoma |
| D001932 | Brain Neoplasms |
| D008527 | Medulloblastoma |
| D004806 | Ependymoma |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| D018242 | Neuroectodermal Tumors, Primitive |
| D020339 | Optic Nerve Glioma |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| C531673 | Familial ependymoma |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
| D019572 | Retinal Neoplasms |
| D015785 | Eye Diseases, Hereditary |
| D012164 | Retinal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019574 | Optic Nerve Neoplasms |
| D003390 | Cranial Nerve Neoplasms |
| D010524 | Peripheral Nervous System Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009901 | Optic Nerve Diseases |
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