Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
Study Details
Study Description
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 metastases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
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Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
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Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
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Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed malignancy expressing GD2, including, but not limited to:
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Medulloblastoma/primitive neuroectodermal tumor of the CNS
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Malignant glioma
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Neuroblastoma
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Retinoblastoma
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Ependymoma
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Sarcoma
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Melanoma
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Small cell lung carcinoma
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Other tumor types must have GD2 expression confirmed by immunohistochemical staining
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Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
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Prior measurable human anti-mouse monoclonal antibody titer allowed
PATIENT CHARACTERISTICS:
Age:
- 3 and over
Performance status:
- Not specified
Life expectancy:
- At least 2 months
Hematopoietic:
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Absolute neutrophil count greater than 1,000/mm^3
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Platelet count greater than 50,000/mm^3
Hepatic:
- Bilirubin less than 3 mg/dL
Renal:
-
Creatinine less than 2 mg/dL
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Blood urea nitrogen less than 30 mg/dL
Other:
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May have active malignancy outside the central nervous system
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No obstructive hydrocephalus
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No CNS grade 3 or 4 toxicity as a consequence of prior treatments
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No life threatening infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Prior monoclonal antibody treatment allowed
Chemotherapy:
-
Prior chemotherapy allowed
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Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
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Prior radiotherapy allowed
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At least 6 weeks since prior cranial or spinal irradiation
Surgery:
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Kim Kramer, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 97-021
- CDR0000065607
- NCI-G97-1267