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Cancer and Blood Pressure Management, CARISMA Study
This phase II trial studies how well intensive blood pressure management works in decreasing
systolic blood pressure in patients with kidney or thyroid cancer that has spread to other
places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor
cancer therapy. This study is being done to find out if a systolic blood pressure to a target
of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well
tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg
while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors
understand the best way to control blood pressure in kidney or thyroid cancer patients taking
anti-angiogenic tyrosine kinase inhibitor.
• English speaking
• Patient must have histologically or cytologically-proven advanced metastatic renal
cell cancer (mRCC) or medullary thyroid cancer initially treated with anti-angiogenic
tyrosine kinase inhibitors (AA-TKIs) including: sunitinib, sorafenib, pazopanib,
cabozantinib, lenvatinib, vandetanib, or axitinib)
• NOTE: If patient has a severe sulfa allergy (e.g. Stevens Johnson reaction), then
alternative non-sulfa medications can be considered in consultation with the
C-BAC. Patient with a noted severe allergic reactions to medications listed in
the algorithms is not necessarily excluded from this trial, as alternative
medications could be considered in consultation with the C-BAC. Moreover, the
patient treated with pre-existing medications that may interact with proposed BP
medications is not necessarily excluded, as alternative medications exist. The
clinical significance of any potential drug interactions can also be addressed
with the C-BAC.
• Prior exposure to another AA-TKI is permissible. Concurrent or prior treatment with
immunotherapy is also permissible
• Patient must have either clinical cardiovascular (CV) disease or evidence of increased
CV risk as defined by one or more of the following:
• Clinical CV disease (history of myocardial infarction [MI] acute coronary
syndrome, coronary revascularization, carotid endarterectomy or stenting greater
than 3 months prior to registration, peripheral artery disease, cerebrovascular
accident greater than 3 months prior to registration, abdominal aortic aneurysm
or heart failure [HF])
• An American College of Cardiology/American Heart Association (ACC/AHA) CV risk
score of at least 10%
• Chronic kidney disease (defined as an estimated glomerular filtration rate [eGFR]
between 30 and 60 ml/min per 1.73 m^2). Dialysis patients and patients with an
eGFR < 30 ml/min/1.73m^2 will be excluded. eGFR will be calculated according to
the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
• Patient must have systolic blood pressure (SBP) >= 130 mmHg on two or more occasions
according to any in-clinic visit in the 12 weeks prior to or during their initial 4
weeks of treatment with an AA-TKI. Patient who have a prior diagnosis of hypertension
or on pre-existing anti-hypertensive medications are eligible for enrollment. However,
patient must not be on more than 3 baseline blood pressure medications at time of
entry
• NOTE: If a patient has a single elevated SBP >= 130mmHg but not on repeat
assessment, an additional SBP assessment should be performed to confirm
ineligibility
• Patient must agree to comply with performing home blood pressure monitoring using an
Omron7250 oscillometric monitor at home, or equivalent models
• Women of childbearing potential and sexually active males must be strongly advised to
use accepted and effective methods of contraception or to abstain from sexual
intercourse for the duration of their participation in the study
• Patient must have internet access through a computer, tablet, or smart phone to use
EASEE-PRO and home BP monitoring. A valid phone number to receive text messages and
email address are also necessary
• Leukocytes >= 3,000/mcL (obtained within 14 days prior to registration)
• Absolute neutrophil count >= 1,500/mcL (obtained within 14 days prior to registration)
• Platelets >= 100,000/mcL (obtained within 14 days prior to registration)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to
registration)
• Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral
load must be undetectable on suppressive therapy, if indicated
• Patient with a history of hepatitis C virus (HCV) infection must have been treated and
cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
• Patient with treated brain metastases are eligible if follow-up brain imaging after
central nervous system (CNS)-directed therapy shows no evidence of progression
• Patient with new or progressive brain metastases (active brain metastases) or
leptomeningeal disease are eligible if the treating physician determines that
immediate CNS specific treatment is not required and is unlikely to be required during
the first cycle of therapy
• Patient with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
• Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
• Patient must not have end-stage renal failure on dialysis, history of repeated
hyperkalemia with a potassium > 5.5 mEq/l, or have a kidney transplant, or an eGFR <
30 ml/min/1.73 m^2
• Patient must not have coronary artery bypass grafting, MI acute coronary syndrome
severe/unstable angina, stroke, transient ischemic attack, clinically significant
bleeding requiring hospitalization or pulmonary embolism within 3 months prior to
registration
• Patient must not have brain surgery or radiotherapy within 2 weeks prior to
registration
• Patient must not have uncontrolled blood pressure defined by SBP > 160 mmHg on three
or more antihypertensives prior to TKI initiation
• Patient with an arm circumference too large (> 50 cm) or small (< 17 cm) to allow
accurate BP measurement with available devices will not be eligible
• Women must not be pregnant or breast-feeding due to the potential harm to an unborn
fetus and possible risk for adverse events in nursing infants with some
anti-hypertensives, including angiotensin receptor blockers. All females of
childbearing potential must have a blood test or urine study within 14 days prior to
registration to rule out pregnancy. A female of childbearing potential is defined as
any woman, regardless of sexual orientation or whether they have undergone tubal
ligation, who meets the following criteria: has achieved menarche at some point, has
not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally
postmenopausal (amenorrhea following cancer therapy does not rule out childbearing
potential) for at least 24 consecutive months (i.e., has had menses at any time in the
preceding 24 consecutive months)