Degradation of Top2b and Top2a in Human by Dexrazoxane, Effects of Dexrazoxane on Healthy Human, Time Course and Degradation of Top2b in Human by Dexrazoxane
Conditions
Keywords
Dexrazoxane, Topoisomerase 2b, Human, Doxorubicin cardio-toxicity, Cardio-oncology, Onco-cardiology, Prevention of cardio-toxicity by doxorubicin, Early administration of dexrazoxane
Brief summary
The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.
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
Interventions
DRUGDexrazoxane
One dose of dexrazoxane
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Each subject will receive one dose of dexrazoxane.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Women, * Age 18-65, * Not pregnant, Not currently breast feeding * No current illness,
Exclusion criteria
* Pregnancy, currently breast feeding * Current illness, * History of cardiac, or renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With 95% Reduction in Topoisomerase 2 b From Baseline | 8 hours after dexrazoxane administration | Number of participants with 95% reduction in topoisomerase 2 b from baseline is reported in the Outcome Measure Data Table |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexrazoxane 100mg/m2 one dose of 100mg/m2 dexrazoxane
Dexrazoxane: One dose of dexrazoxane | 5 |
| Dexrazoxane 200mg/m2 one dose of 200mg/m2 dexrazoxane
Dexrazoxane: One dose of dexrazoxane | 5 |
| Dexrazoxane 300mg/m2 one dose of 300mg/m2 dexrazoxane
Dexrazoxane: One dose of dexrazoxane | 5 |
| Dexrazoxane 400mg/m2 one dose of 400mg/m2 dexrazoxane
Dexrazoxane: One dose of dexrazoxane | 5 |
| Dexrazoxane 500mg/m2 one dose of 500 mg/m2
Dexrazoxane: One dose of dexrazoxane | 5 |
| Total | 25 |
Baseline characteristics
| Characteristic | Dexrazoxane 100mg/m2 | Dexrazoxane 200mg/m2 | Dexrazoxane 300mg/m2 | Dexrazoxane 400mg/m2 | Dexrazoxane 500mg/m2 | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 19 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 5 participants | 5 participants | 25 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 3 / 5 | 1 / 5 | 2 / 5 | 0 / 5 | 3 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Participants With 95% Reduction in Topoisomerase 2 b From Baseline
Number of participants with 95% reduction in topoisomerase 2 b from baseline is reported in the Outcome Measure Data Table
Time frame: 8 hours after dexrazoxane administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexrazoxane 100mg/m2 | Participants With 95% Reduction in Topoisomerase 2 b From Baseline | 0 Participants |
| Dexrazoxane 200mg/m2 | Participants With 95% Reduction in Topoisomerase 2 b From Baseline | 0 Participants |
| Dexrazoxane 300mg/m2 | Participants With 95% Reduction in Topoisomerase 2 b From Baseline | 0 Participants |
| Dexrazoxane 400mg/m2 | Participants With 95% Reduction in Topoisomerase 2 b From Baseline | 0 Participants |
| Dexrazoxane 500mg/m2 | Participants With 95% Reduction in Topoisomerase 2 b From Baseline | 1 Participants |