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| Descriptive Information Fields | |||||
| Brief Title † | Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer | ||||
| Official Title † | Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin) Neuroblastoma Retinoblastoma Sarcoma |
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| Intervention † | Drug: iodine I 131 monoclonal antibody 3F8 | ||||
| MEDLINE PMIDs | 18048828 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | April 1997 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
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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| Gender | Both | ||||
| Ages | 3 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00003022 | ||||
| Organization ID | CDR0000065607 | ||||
| Secondary IDs †† | MSKCC-97021, NCI-G97-1267 | ||||
| Study Sponsor † | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2005 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||