Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
iodine I 131 monoclonal antibody 3F8
Brain Diseases+55
+ Bronchial Neoplasms
+ Carcinoma, Bronchogenic
Treatment Study
Summary
Study start date: April 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 3 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps