Cancer Therapy Risk-Reduction With Intensive Systolic BP Management (CARISMA) - a Phase II Study

Plain English Summary

Cancer and Blood Pressure Management, CARISMA Study is a Not Applicable clinical trial sponsored by ECOG-ACRIN Cancer Research Group studying Cardiovascular Disorder, Chronic Kidney Disease, Metastatic Renal Cell Carcinoma, Metastatic Thyroid Gland Medullary Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Stage IV Thyroid Gland Medullary Carcinoma 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. This trial tests if a more intensive approach to managing blood pressure (target <120 mmHg) is safe and effective compared to standard management (target <140 mmHg) in patients with advanced kidney or thyroid cancer starting a specific type of cancer therapy. It is for patients with advanced (metastatic) kidney or thyroid cancer who are beginning treatment with anti-angiogenic tyrosine kinase inhibitors (AA-TKIs). Participation involves regular blood pressure monitoring at home and in the clinic, and potentially adjusting blood pressure medications. Alternative options include standard blood pressure management as advised by a doctor, without the intensive monitoring and target goals of this trial. The trial aims to enroll 61 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You may be eligible if you have advanced kidney or thyroid cancer that has spread, are starting a specific cancer therapy (AA-TKI), and have a history of or increased risk for cardiovascular disease. You may also be eligible if you have chronic kidney disease (eGFR between 30-60) or have had high blood pressure readings. You cannot join if you have end-stage kidney failure requiring dialysis or a history of repeated high potassium levels. Participants must be English-speaking, have internet access for monitoring, and agree to use effective contraception if of childbearing potential or sexually active. This trial is studying Cardiovascular Disorder, Chronic Kidney Disease, Metastatic Renal Cell Carcinoma, Metastatic Thyroid Gland Medullary Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Stage IV Thyroid Gland Medullary Carcinoma 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, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how well the intensive blood pressure management strategy lowers systolic blood pressure over 6 months, indicating its effectiveness in reaching the target goal. The specific primary outcome measures are: Differences in systolic blood pressure (SBP) based on automated office BP measurements (Up to 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses the significant risk of cardiovascular side effects from common cancer therapies, aiming to find a better way to manage blood pressure and potentially improve patient outcomes. This research targets Cardiovascular Disorder, Chronic Kidney Disease, Metastatic Renal Cell Carcinoma, Metastatic Thyroid Gland Medullary Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Stage IV Thyroid Gland Medullary Carcinoma 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, where improved treatment options are needed.

Investor Insight

This trial focuses on a critical unmet need in oncology supportive care, potentially improving the tolerability of important cancer treatments and expanding their use, which could be a significant mar

Is This Trial Right for Me?

Ask your doctor if this trial is right for you, especially regarding your specific cancer type, treatment, and cardiovascular health. Be prepared for frequent blood pressure checks at home and at the clinic, and potential adjustments to your blood pressure medications. You will need reliable internet access for remote monitoring and data entry. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 61 participants

Interventions

• OTHER: Best Practice — Receive usual blood pressure management
• OTHER: Blood Pressure Measurement — Undergo blood pressure measurement
• OTHER: Clinical Management — Undergo intensive systolic BP management
• OTHER: Quality-of-Life Assessment — Ancillary studies
• OTHER: Questionnaire Administration — Ancillary studies

Primary Outcomes

• Differences in systolic blood pressure (SBP) based on automated office BP measurements (Up to 6 months)

Secondary Outcomes

• 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)

Full Eligibility Criteria

Inclusion Criteria:

* 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 

Trial Locations

• Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
• Washington University School of Medicine, St Louis, Missouri, United States
• Montefiore Medical Center-Einstein Campus, The Bronx, New York, United States
• Montefiore Medical Center-Weiler Hospital, The Bronx, New York, United States
• Montefiore Medical Center - Moses Campus, The Bronx, New York, United States
• University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
• University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
• UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
• Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, United States
• Aurora Saint Luke's South Shore, Cudahy, Wisconsin, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Cardiovascular Disorder
• Chronic Kidney Disease
• Metastatic Renal Cell Carcinoma
• Metastatic Thyroid Gland Medullary Carcinoma
• Renal Cell Cancer
• Thyroid Gland Medullary Carcinoma
• Hypertension
• Cancer Therapy Side Effects
• Oncology Supportive Care
• Tyrosine Kinase Inhibitor Therapy

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