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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003022 |
Purpose
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 cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin) Neuroblastoma Retinoblastoma Sarcoma |
Radiation: iodine I 131 monoclonal antibody 3F8 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms |
| Study Start Date: | April 1997 |
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.
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy expressing GD2, including, but not limited to:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Kim Kramer, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000065607, MSKCC-97021, NCI-G97-1267 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003022 History of Changes |
| Health Authority: | United States: Federal Government |
|
metastatic osteosarcoma childhood infratentorial ependymoma recurrent childhood rhabdomyosarcoma childhood supratentorial ependymoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma retinoblastoma intraocular retinoblastoma extraocular retinoblastoma recurrent retinoblastoma extensive stage small cell lung cancer recurrent small cell lung cancer recurrent osteosarcoma |
recurrent adult brain tumor iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma adult brain stem glioma adult medulloblastoma stage IV melanoma recurrent melanoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma adult myxopapillary ependymoma adult anaplastic ependymoma adult anaplastic oligodendroglioma |
|
Thoracic Neoplasms Retinal Neoplasms Glioblastoma Meningeal Neoplasms Neuroectodermal Tumors, Primitive Central Nervous System Neoplasms Retinoblastoma Neoplasms, Connective and Soft Tissue Lung Neoplasms Iodine Neuroepithelioma Osteogenic Sarcoma Glioma Nervous System Neoplasms Immunoglobulins |
Rhabdomyosarcoma Eye Neoplasms Astrocytoma Ewing's Sarcoma Carcinoma, Small Cell Brain Neoplasms Neuroectodermal Tumors Malignant Mesenchymal Tumor Brain Stem Glioma, Childhood Lung Diseases Sarcoma Nevus Neoplasms, Glandular and Epithelial Immunologic Factors Uveal Melanoma |
|
Retinal Neoplasms Thoracic Neoplasms Meningeal Neoplasms Neuroectodermal Tumors, Primitive Immunologic Factors Physiological Effects of Drugs Neoplasms, Nerve Tissue Central Nervous System Neoplasms Retinoblastoma Neuroblastoma Melanoma Antibodies, Monoclonal Neoplasms, Connective and Soft Tissue Neoplasms by Site Respiratory Tract Diseases |
Lung Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Retinal Diseases Nervous System Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Eye Neoplasms Eye Diseases Nervous System Diseases Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Antibodies Neoplasms |