Clinical Trials Directory

Trials / Terminated

TerminatedNCT00852709

Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
35 (estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
Sex
All
Age
1 Year – 21 Years
Healthy volunteers
Not accepted

Summary

This is a Phase I study designed to determine the MTD and assess the toxicity associated with clofarabine followed by fractionated cyclophosphamide in patients \> 1 year of age or \< 21 years of age with relapsed or refractory acute leukemias. There will be 25 to 35 patients enrolled. Cohorts of 3 to 6 patients each will receive escalated doses of clofarabine followed by fractionated cyclophosphamide until the MTD is reached. There will be no intra-patient dose escalation. Single-agent cyclophosphamide will be administered by 2-hour IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide (see the treatment schema below). A cycle is defined as 28 days.

Conditions

Interventions

TypeNameDescription
DRUGClofarabineOn Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide
DRUGCyclophosphamideSingle-agent cyclophosphamide will be administered by 2-hour IVI on Day 0 of cycle 1. On Days 1, 2, and 3 and Days 8, 9, and 10 clofarabine will be administered by IVI 2 hours before each dose of cyclophosphamide

Timeline

Start date
2007-09-01
Primary completion
2009-11-20
Completion
2009-11-20
First posted
2009-02-27
Last updated
2018-02-15

Locations

7 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT00852709. Inclusion in this directory is not an endorsement.