MDA 2007-0914A - "A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)"

NOTES: 

1)  Equipment & training for the Biosite Triage Profiler (Biosite) is provided.  A training video is available here.

2)  Each site must be certified for using Biosite prior to registering the 1st pt to the protocol.

Treatment Plan    (Supplied Drug:  N/A)

Within 14 days of starting anthracycline-based chemo

H&P (including neck, cardiovascular, lung, abdomen, extremities, & other exams as needed) - see protocol for requirements

Cardiomyopathy Risk Factor Asmt

MD Anderson Symptom Index - Heart Failure Questionnaire

Cardiac Symptom Review

Cardiac Med Evaluation

Cardiac Diagnosis Log

Within 30 days of starting anthracycline-based chemo

BNP & Troponin I - performed using BIOSITE*

TSH, lipid profile, serum chemistry panel (Chem 8+ or similar), CBC

Echo & EKG at baseline (Echo is strongly preferred; use same method throughout tx)

Within 60 days of starting anthracycline-based chemo

EKG (b/f chemo)

Within 90 days of starting anthracycline-based chemo

TSH

Prior to each cycle of anthracycline-based chemo (or at least q4wks w/other chemo regimens)

PE (including neck, cardiovascular, lung, abdomen, extremities, & other exams as needed) - see protocol for requirements

Cardiac Symptom Review

BNP & Troponin I - performed using BIOSITE*

Concomitant Meds

All standard labs (Chem 8+ or similar, CBC) as part of standard care

Prior to every 3rd cycle of chemo

MD Anderson Symptom Index - Heart Failure Questionnaire

6 months (+1 month) & 12 months (+1 month) after initiation of chemo

PE (including neck, cardiovascular, lung, abdomen, extremities, & other exams as needed) - see protocol for requirements

Cardiac Symptom Review

BNP & Troponin I - performed using BIOSITE*

TSH, lipid profile, serum chemistry panel (Chem 8+ or similar), CBC

MD Anderson Symptom Index - Heart Failure Questionnaire

Echo & EKG

*  Pts w/abnormal Troponin (>0.4ng/ml) or BNP >200 will be referred to a consulting cardiologist for optimal tx w/i 1 wk of abnormal value.

Eligibility

• Age 18-85.

• Starting new course of chemo that includes an anthracycline (does not have to be 1st line therapy).  Prior anthracycline is allowed.

• Life expectancy >12 mos.

• No unstable angina w/i 3 mos pre-regist.

• No MI w/i 3 mos pre-regist.

• No LVEF <50%.

• No concurrent dexrazoxane.

• No decompensated heart failure w/i 3 mos pre-regist.

• No prior symptomatic arrhythmia (w/i 3 mos).

• No severe pulmonary disease (FEV <1.0 liters) &/or pulmonary HTN (mean pulmonary artery pressure >60mmHg) &/or dependent use of oxygen.

• No BNP >200pg/ml or troponin >0.4ng/ml using the Biosite Triage Profiler.  NOTE:  BNP &/or Tnl results from local lab w/i 30 days of starting anthracycline-based chemo may be subsituted. 

• BASELINE REQUIREMENTS:

  • BNP

  • Troponin

  • Baseline Asmts

  • Chem 8+/CBS/TSH/Lipids

  • Cardiac Diagnostic Eval:  Echo (preferred) or MUGA, EKG

  • PE

  • Cardiac Symptom Review

  • MD Anderson Symptom Index - Heart Failure Questionnare

  • Optional Biomarker sample

• Signed informed consent.