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NCT00014495 · OUTCOME

Maximum Tolerated Dose

Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer · Source last updated 2016-01-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
mCi/kg
Interval / dispersion
Not reported
Time frame
2 years

What was measured

The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.

Groups in this outcome

Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine

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. Cohorts 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. Patients are followed twice weekly for 4 weeks and then monthly for 3 months filgrastim cytarabine bismuth Bi213 monoclonal antibody M195

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine20

Reported measurements

Source class 1
Values in mCi/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      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
  1. 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. Cohorts 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. Patients are followed twice weekly for 4 weeks and then monthly for 3 months filgrastim cytarabine bismuth Bi213 monoclonal antibody M195
    id
    OG000
    title
    Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Maximum Tolerated Dose
type
PRIMARY
unit Of Measure
mCi/kg

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice