{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"}],"units":"Participants"}],"description":"The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.","groups":[{"description":"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.\n\nPatients are followed twice weekly for 4 weeks and then monthly for 3 months\n\nfilgrastim\n\ncytarabine\n\nbismuth Bi213 monoclonal antibody M195","id":"OG000","title":"Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"2 years","title":"Maximum Tolerated Dose","type":"PRIMARY","unitOfMeasure":"mCi/kg"}