Melanoma Clinical Trial
Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
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.
Full Description
OBJECTIVES:
Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy expressing GD2, including, but not limited to:
Medulloblastoma/primitive neuroectodermal tumor of the CNS
Malignant glioma
Neuroblastoma
Retinoblastoma
Ependymoma
Sarcoma
Melanoma
Small cell lung carcinoma
Other tumor types must have GD2 expression confirmed by immunohistochemical staining
Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
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:
Absolute neutrophil count greater than 1,000/mm^3
Platelet count greater than 50,000/mm^3
Hepatic:
Bilirubin less than 3 mg/dL
Renal:
Creatinine less than 2 mg/dL
Blood urea nitrogen less than 30 mg/dL
Other:
May have active malignancy outside the central nervous system
No obstructive hydrocephalus
No CNS grade 3 or 4 toxicity as a consequence of prior treatments
No life threatening infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Prior monoclonal antibody treatment allowed
Chemotherapy:
Prior chemotherapy allowed
Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
Prior radiotherapy allowed
At least 6 weeks since prior cranial or spinal irradiation
Surgery:
Not specified
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There is 1 Location for this study
New York New York, 10021, United States
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