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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
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 metastases.
| 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: | Primary Purpose: 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
| ClinicalTrials.gov Identifier: | NCT00003022 History of Changes |
| Other Study ID Numbers: | CDR0000065607, MSKCC-97021, NCI-G97-1267 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 22, 2010 |
| 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 |
|
Lung Neoplasms Melanoma Nervous System Neoplasms Neuroblastoma Retinoblastoma Central Nervous System Neoplasms Neuroectodermal Tumors, Primitive Uveal Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Meningeal Neoplasms Sarcoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Nervous System Diseases Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Retinal Neoplasms Eye Neoplasms Eye Diseases Retinal Diseases |