Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


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.


Study summary:

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.


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


NCT ID:

NCT00003022


Primary Contact:

Study Chair
Kim Kramer, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.