Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane (PHOENIX1)

University of Arkansas

Status and phase: Completed; Phase 1

Conditions: Time Course and Degradation of Top2b in Human by Dexrazoxane; Effects of Dexrazoxane on Healthy Human; Degradation of Top2b and Top2a in Human by Dexrazoxane

Treatments: Drug: Dexrazoxane

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03930680

R01HL151993 (U.S. NIH Grant/Contract)

262180

Details and patient eligibility

About

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

Full 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

Enrollment: 25 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 5 patient groups

Dexrazoxane 100mg/m2

Experimental group

Description:

one dose of 100mg/m2 dexrazoxane

Treatment:

Drug: Dexrazoxane

Dexrazoxane 200mg/m2

Experimental group

Description:

one dose of 200mg/m2 dexrazoxane

Treatment:

Drug: Dexrazoxane

Dexrazoxane 300mg/m2

Experimental group

Description:

one dose of 300mg/m2 dexrazoxane

Treatment:

Drug: Dexrazoxane

Dexrazoxane 400mg/m2

Experimental group

Description:

one dose of 400mg/m2 dexrazoxane

Treatment:

Drug: Dexrazoxane

Dexrazoxane 500mg/m2

Experimental group

Description:

one dose of 500 mg/m2

Treatment:

Drug: Dexrazoxane