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| Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00445965 |
Purpose
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal cancer.
PURPOSE: This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin) Metastatic Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma Small Intestine Cancer |
Other: immunologic technique Other: pharmacological study Radiation: iodine I 131 monoclonal antibody 3F8 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms |
| Estimated Enrollment: | 34 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive intrathecal iodine I 124 monoclonal antibody 3F8 for dosimetry. Beginning approximately 1 week later, patients receive intrathecal iodine I 131 monoclonal antibody 3F8 on day 1. Treatment intrathecal iodine I 131 monoclonal antibody 3F8 repeats weekly for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood and cerebrospinal fluid samples are collected prior to and after administration of each course of study drug. Samples are analyzed to assess the intrathecal and blood pharmacokinetics of iodine I 131 monoclonal antibody 3F8 and serum human antimouse antibodies.
After completion of study treatment, patients are followed periodically for 3 months.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed GD2-expressing malignancy, including the following:
Must meet 1 of the following criteria:
Patients with active malignancy outside the central nervous system are eligible
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Kim Kramer, MD 212-639-6410 kramerk@mskcc.org | |
| Study Chair: | Kim Kramer, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Kim Kramer ) |
| Study ID Numbers: | CDR0000534394, MSKCC-05122 |
| Study First Received: | March 7, 2007 |
| Last Updated: | April 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00445965 History of Changes |
| Health Authority: | Unspecified |
|
leptomeningeal metastases recurrent childhood medulloblastoma untreated childhood medulloblastoma adult supratentorial primitive neuroectodermal tumor (PNET) recurrent childhood supratentorial primitive neuroectodermal tumor untreated childhood supratentorial primitive neuroectodermal tumor adult anaplastic astrocytoma adult diffuse astrocytoma adult pilocytic astrocytoma adult subependymal giant cell astrocytoma recurrent childhood subependymal giant cell astrocytoma untreated childhood subependymal giant cell astrocytoma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma untreated childhood cerebellar astrocytoma |
adult brain stem glioma adult mixed glioma childhood mixed glioma recurrent childhood brain stem glioma recurrent childhood visual pathway and hypothalamic glioma recurrent childhood visual pathway glioma untreated childhood brain stem glioma untreated childhood visual pathway and hypothalamic glioma untreated childhood visual pathway glioma regional neuroblastoma disseminated neuroblastoma recurrent neuroblastoma extraocular retinoblastoma recurrent retinoblastoma adult anaplastic ependymoma |
|
Retinal Neoplasms Thoracic Neoplasms Glioblastoma Meningeal Neoplasms Neuroectodermal Tumors, Primitive Urogenital Neoplasms Central Nervous System Neoplasms Retinoblastoma Ileal Diseases Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Lung Neoplasms Neoplasm Metastasis Iodine Osteogenic Sarcoma |
Neuroepithelioma Ovarian Cancer Glioma Nervous System Neoplasms Immunoglobulins Rhabdomyosarcoma Endocrine Gland Neoplasms Digestive System Neoplasms Astrocytoma Eye Neoplasms Genital Neoplasms, Female Endocrine System Diseases Ewing's Sarcoma Carcinoma, Small Cell Anti-Infective Agents, Local |
|
Thoracic Neoplasms Retinal Neoplasms Anti-Infective Agents Meningeal Neoplasms Neuroectodermal Tumors, Primitive Physiological Effects of Drugs Urogenital Neoplasms Central Nervous System Neoplasms Retinoblastoma Ileal Diseases Duodenal Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Site Pathologic Processes Lung Neoplasms |
Therapeutic Uses Neoplasm Metastasis Iodine Glioma Nervous System Neoplasms Endocrine Gland Neoplasms Digestive System Neoplasms Astrocytoma Eye Neoplasms Nervous System Diseases Genital Neoplasms, Female Endocrine System Diseases Anti-Infective Agents, Local Neuroectodermal Tumors Neoplasms |
