Purpose

The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Women, - Age 18-65, - Not pregnant, Not currently breast feeding - No current illness, - Not on prescribed medication,or nutritional supplement

Exclusion Criteria

  • Pregnancy, currently breast feeding - Current illness, - On prescribed medication or nutritional supplement - History of cardiac, or renal disease

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Each subject will receive one dose of dexrazoxane.
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dexrazoxane 100mg/m2
one dose of 100mg/m2 dexrazoxane
  • Drug: Dexrazoxane
    One dose of dexrazoxane
    Other names:
    • Zinecard
Experimental
Dexrazoxane 200mg/m2
one dose of 200mg/m2 dexrazoxane
  • Drug: Dexrazoxane
    One dose of dexrazoxane
    Other names:
    • Zinecard
Experimental
Dexrazoxane 300mg/m2
one dose of 300mg/m2 dexrazoxane
  • Drug: Dexrazoxane
    One dose of dexrazoxane
    Other names:
    • Zinecard
Experimental
Dexrazoxane 400mg/m2
one dose of 400mg/m2 dexrazoxane
  • Drug: Dexrazoxane
    One dose of dexrazoxane
    Other names:
    • Zinecard
Experimental
Dexrazoxane 500mg/m2
one dose of 500 mg/m2
  • Drug: Dexrazoxane
    One dose of dexrazoxane
    Other names:
    • Zinecard

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Hui-Ming Chang, PhD
501-526-6000
hchang@uams.edu

More Details

NCT ID
NCT03930680
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

Hui-Ming Chang, MD,MPH
501-5266000
hchang@uams.edu

Detailed Description

This is a study on volunteers to determine effective dose of dexrazoxane in degrading Topoisomerase 2 b in human blood samples. Each participant will receive one dose of dexrazoxane. Blood samples will be collected to determine the time course and degradation of Topoisomerase 2b and Topoisomerase 2a

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.