Cancer and Blood Pressure Management, CARISMA Study

NCT04467021 | Active Not Recruiting DMC

• 4 other identifiers: EAQ191NCI-2020-00900ECOG-ACRIN-EAQ191UG1CA189828
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Cardiovascular Disorder; Chronic Kidney Disease; Metastatic Renal Cell Carcinoma; Metastatic Thyroid Gland Medullary Carcinoma; Stage IV Renal Cell Cancer AJCC v8; Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8; Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8; Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8; Stage IV Thyroid Gland Medullary Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• Differences in systolic blood pressure (SBP) based on automated office BP measurements

  Differences in SBP over the 6- month study period between intensive BP control (intervention) versus standard care (non-intervention group) will be compared using the "difference-indifference" method. All mixed effects models will be estimated using generalized estimating equations (GEE).

  Up to 6 months

Secondary Outcomes (8)

• Difference in SBP based on all automated home and office BP measurements

  Up to 6 months

• Study retention rates

  Up to 6 months

• Frequency of automated home SBP measurements > 180 mmHg or < 90 mmHg or diastolic (D)BP > 110 mmHg

  Up to 6 months

• Differences in symptoms and health-related quality of life

  Up to 6 months

• Differences in patient-reported medication compliance

  Up to 6 months

Other Outcomes (1)

• Incidence of significant cardiovascular (CV) events

  Up to 6 months

Study Arms (2)

Arm A (intensive systolic blood pressure management)

EXPERIMENTAL

Patients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks, and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).

Other: Blood Pressure Measurement; Other: Clinical Management; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm B (usual blood pressure management)

ACTIVE COMPARATOR

Patients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks, and upload the recorded blood pressures to a central monitoring team.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (intensive systolic blood pressure management); Arm B (usual blood pressure management)

Best Practice OTHER

Receive usual blood pressure management

Also known as: standard of care, standard therapy

Arm B (usual blood pressure management)

Blood Pressure Measurement OTHER

Undergo blood pressure measurement

Arm A (intensive systolic blood pressure management)

Clinical Management OTHER

Undergo intensive systolic BP management

Arm A (intensive systolic blood pressure management)

Questionnaire Administration OTHER

Ancillary studies

Arm A (intensive systolic blood pressure management); Arm B (usual blood pressure management)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (25)

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105, United States

Location

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, 53110, United States

Location

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022, United States

Location

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024, United States

Location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142, United States

Location

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143, United States

Location

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209, United States

Location

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904, United States

Location

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406, United States

Location

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081, United States

Location

Aurora Medical Center in Summit

Summit, Wisconsin, 53066, United States

Location

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, 54241, United States

Location

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226, United States

Location

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States

Location

Related Publications (1)

• Narayan V, Liu T, Song Y, Mitchell J, Sicks J, Gareen I, Sun L, Denduluri S, Fisher C, Manikowski J, Wojtowicz M, Vadakara J, Haas N, Margulies KB, Ky B. Early Increases in Blood Pressure and Major Adverse Cardiovascular Events in Patients With Renal Cell Carcinoma and Thyroid Cancer Treated With VEGFR TKIs. J Natl Compr Canc Netw. 2023 Oct;21(10):1039-1049.e10. doi: 10.6004/jnccn.2023.7047.

  PMID: 37856199 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency, Chronic; Carcinoma, Renal Cell; Carcinoma, Medullary

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Bonnie Ky

  ECOG-ACRIN Cancer Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: October 29, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (25)