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Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT03475186
Collaborator
National Cancer Institute (NCI) (NIH)
75
Enrollment
421
Locations
1
Arm
55.2
Anticipated Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patients will be followed until 5 months post chemoradiation for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy
Actual Study Start Date :
Mar 25, 2019
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ramipril

Ramipril will be taken once daily by mouth. It will be titrated during the first 3 weeks of chemoradiation to the highest tolerable dose (2.5-5 mg). This dose will be taken each day until 4 months post-chemoradiation treatment (22 weeks).

Drug: Ramipril
2.5 - 5 mg oral, 1x daily for 22 weeks
Other Names:
  • Altace
  • Tritace

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline Neurocognitive Function at 10 weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) [Baseline,10 weeks]

      HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R.

    2. Change from Baseline Neurocognitive Function at 10 weeks - Trail Making Test Part A and B (TMT A & B) [Baseline,10 weeks]

      Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. TMT-B is similar except subjects are required to connect dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The score for TMT-A and TMT-B is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected.

    3. Change from Baseline Neurocognitive Function at 10 weeks - Controlled Oral Word Association Test (COWA) [Baseline,10 weeks]

      The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter (F-A-S). The score on the COWA is the total number of words named across the three trials minus repetitions.

    4. Efficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary [Baseline]

      Provides an assessment of premorbid intellectual functioning comparable to a verbal IQ and thus is a proxy for cognitive reserve. This vocabulary test requires respondents to read a target word and select one of four words that most closely means the same thing. Score is total correct of 40 items and will be used in conjunction with the other neurocognitive results.

    5. Retention Rate at 10 weeks [10 weeks]

      Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests

    Secondary Outcome Measures

    1. Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) [Baseline, 6 weeks, 10 weeks, 22 weeks]

      A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization.

    2. Estimate Time of Neurocognitive Decline- HVLT-R [Baseline - 22 weeks]

      Measured by the first significant decline of the HVLT-R.

    3. Estimate Time of Neurocognitive Decline- TMT A & B [Baseline - 22 weeks]

      Measured by the first significant decline of the TMT A & B

    4. Estimate Time of Neurocognitive Decline- COWA [Baseline - 22 weeks]

      Measured by the first significant decline of the COWA

    5. Determine Presence of Apolipoprotein Epsilon (ApoE) [Baseline]

      Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test

    6. Efficacy of neurocognitive function in surviving patients- HVLT-R [22 weeks]

      Comparison of HVLT-R results between groups at study end.

    7. Efficacy of neurocognitive function in surviving patients- TMT A & B [22 weeks]

      Comparison of TMT A & B results between groups at study end.

    8. Efficacy of neurocognitive function in surviving patients- COWA [22 weeks]

      Comparison of COWA results between groups at study end.

    9. Efficacy of neurocognitive function in surviving patients- EORTCQLQ30/BN20 [22 weeks]

      Comparison of EORTCQLQ30/BN20 results between groups at study end.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) obtained at the time of a partial or gross total resection of the tumor. Patients who undergo a stereotactic needle biopsy alone are not eligible.

    • The tumor must have a supratentorial component.

    • History/physical examination within 14 days prior to enrollment.

    • The patient must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment

    • Patient planning to receive brain RT, and concurrent and adjuvant temozolomide chemotherapy for six weeks as per standard of care therapy. Use of the Optune® (also known as Tumor Treating Fields or TTFields) device is allowed at provider discretion, but must begin after the Month 1 Post RT (10 week [wk]) Neurocognitive-PRO assessment.

    • Study drug (Ramipril) must be given > 21 days and ≤ 35 days after surgery.

    • All available brain magnetic resonance imaging (MRI) or computed tomography (CT) imaging reports from surgery to study completion must be submitted. This includes any post-operative or pre-radiation scan reports.

    • Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

    • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to enrollment)

    • Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to enrollment)

    • Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (obtained within 14 days prior to enrollment)

    • Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to enrollment

    • Creatinine =< 1.7 mg/dl within 14 days prior to enrollment

    • Total bilirubin =< 2.0 mg/dl within 14 days prior to enrollment

    • Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to enrollment

    • Patient must provide study specific informed consent prior to study entry

    • Baseline potassium level <5.0. High potassium values that are thought to be a result of sample hemolysis may be repeated to determine an accurate potassium level and to determine potential study eligibility. Likewise high potassium values thought to be a result of potassium supplementation may be repeated at an appropriate time (5 half-lives after supplement discontinuation) to determine potential study eligibility.

    Patient must be able to complete neurocognitive tests in the English language

    • Women of childbearing potential and male participants must practice adequate contraception

    • For females of child-bearing potential, negative serum or urine pregnancy test within 14 days of enrollment

    • Local site must be follow the standard GBM radiation treatment dosimetry plan

    • For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following inclusion criteria also apply:

    • Patients must have only a supratentorial glioblastoma

    • The treating physician must be a qualified provider having successfully completed the training course provided by Novocure, the device manufacturer

    • Patients with prior malignancies if all treatment for that malignancy was completed at least 2 years before registration and the patient has no evidence of disease.

    Exclusion Criteria:

    • Prior allergic reaction or intolerance to angiotensin-converting-enzyme (ACE) inhibitor

    • Hypotension (< 110 mg Hg systolic) at the time of enrollment

    • Renal insufficiency with creatinine clearance of < 40 ml/min (at time of enrollment)

    • Solitary kidney or known renal artery stenosis

    • Current ACE inhibitor or angiotensin receptor blocker use. Patients can come off ACE inhibitors or angiotensin receptor blockers for 1 week to be eligible for this study.

    • Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 2 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).

    • Recurrent or multifocal malignant gliomas

    • Metastases detected below the tentorium or beyond the cranial vault

    • Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.

    • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.

    • Severe active co-morbidity, defined as follows:

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment

    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment.

    • Known HIV positivity or acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

    • Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.

    • Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.

    • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

    • Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study.

    • Patients planning to receive therapeutic antitumor agents (excluding use of the Tumor Treating Fields (TTFields or Optune®) device after the Month 1 Post RT (10 wk) Neurocognitive-PRO assessment.) in addition to standard radiation and concurrent and adjuvant temozolomide are not eligible to participate in this study.

    • Patients with impaired decision-making capacity; this exclusion is necessary because such patients may not be able to adequately give informed consent.

    • Pregnant or lactating women, due to possible adverse effect on the developing fetus or infant due to study drug.

    • For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following exclusion criteria also apply:

    • Optune® is not permitted in patients who have an active implanted medical device, skull defect (such as, missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmatic shunts.

    • Optune® is not permitted in patients who are known to be sensitive to conductive hydrogels. Examples of conductive hydrogels are gels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    2 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    3 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    4 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    5 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    6 Anchorage Oncology Centre Anchorage Alaska United States 99508
    7 Katmai Oncology Group Anchorage Alaska United States 99508
    8 Providence Alaska Medical Center Anchorage Alaska United States 99508
    9 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    10 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    11 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    12 Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California United States 93420
    13 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    14 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    15 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
    16 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
    17 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    18 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    19 Saint Francis Cancer Center Colorado Springs Colorado United States 80923
    20 Columbus NCI Community Oncology Research Program Columbus Colorado United States 43215
    21 Porter Adventist Hospital Denver Colorado United States 80210
    22 Mercy Medical Center Durango Colorado United States 81301
    23 Southwest Oncology PC Durango Colorado United States 81301
    24 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
    25 Saint Anthony Hospital Lakewood Colorado United States 80228
    26 Littleton Adventist Hospital Littleton Colorado United States 80122
    27 Littleton Adventist Hospital Littleton Colorado United States 80122
    28 Longmont United Hospital Longmont Colorado United States 80501
    29 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    30 Parker Adventist Hospital Parker Colorado United States 80138
    31 Parker Adventist Hospital Parker Colorado United States 80138
    32 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    33 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
    34 Beebe Medical Center Lewes Delaware United States 19958
    35 Delaware Clinical and Laboratory Physicians PA Newark Delaware United States 19713
    36 Helen F Graham Cancer Center Newark Delaware United States 19713
    37 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    38 Holy Cross Hospital Fort Lauderdale Florida United States 33308
    39 Regional Cancer Center-Lee Memorial Health System Fort Myers Florida United States 33905
    40 Northside Hospital Atlanta Georgia United States 30342
    41 Northside Hospital - Duluth Duluth Georgia United States 30096
    42 Northside Hospital - Gwinnett Lawrenceville Georgia United States 30046
    43 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    44 Suburban Hematology Oncology Associates - Snellville Snellville Georgia United States 30078
    45 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    46 Hawaii Cancer Care - Westridge 'Aiea Hawaii United States 96701
    47 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    48 Queen's Cancer Center - Pearlridge 'Aiea Hawaii United States 96701
    49 Straub Pearlridge Clinic 'Aiea Hawaii United States 96701
    50 The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii United States 96701
    51 The Queen's Medical Center - West Oahu 'Ewa Beach Hawaii United States 96706
    52 Island Urology-Hilo Hilo Hawaii United States 96720
    53 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    54 Island Urology Honolulu Hawaii United States 96813
    55 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    56 Queen's Medical Center Honolulu Hawaii United States 96813
    57 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    58 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    59 Hawaii Diagnostic Radiology Services LLC Honolulu Hawaii United States 96817
    60 Kuakini Medical Center Honolulu Hawaii United States 96817
    61 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    62 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    63 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    64 Straub Medical Center - Kahului Clinic Kahului Hawaii United States 96732
    65 Castle Medical Center Kailua Hawaii United States 96734
    66 Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii United States 96766
    67 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    68 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    69 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    70 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83687
    71 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    72 OSF Saint Anthony's Health Center Alton Illinois United States 62002
    73 Rush-Copley Medical Center Aurora Illinois United States 60504
    74 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    75 Illinois CancerCare-Canton Canton Illinois United States 61520
    76 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    77 SIH Cancer Institute Carterville Illinois United States 62918
    78 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    79 Centralia Oncology Clinic Centralia Illinois United States 62801
    80 John H Stroger Jr Hospital of Cook County Chicago Illinois United States 60612
    81 Carle on Vermilion Danville Illinois United States 61832
    82 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    83 Decatur Memorial Hospital Decatur Illinois United States 62526
    84 Heartland Cancer Research NCORP Decatur Illinois United States 62526
    85 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    86 Carle Physician Group-Effingham Effingham Illinois United States 62401
    87 Crossroads Cancer Center Effingham Illinois United States 62401
    88 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    89 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    90 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    91 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    92 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    93 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    94 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    95 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    96 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    97 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    98 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    99 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    100 Illinois CancerCare-Peru Peru Illinois United States 61354
    101 Valley Radiation Oncology Peru Illinois United States 61354
    102 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    103 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    104 Springfield Clinic Springfield Illinois United States 62702
    105 Memorial Medical Center Springfield Illinois United States 62781
    106 Springfield Memorial Hospital Springfield Illinois United States 62781
    107 Carle Cancer Center NCI Community Oncology Research Program Urbana Illinois United States 61801
    108 Carle Cancer Center Urbana Illinois United States 61801
    109 The Carle Foundation Hospital Urbana Illinois United States 61801
    110 Illinois CancerCare - Washington Washington Illinois United States 61571
    111 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    112 Saint Anthony Regional Hospital Carroll Iowa United States 51401
    113 Saint Luke's Hospital Cedar Rapids Iowa United States 52402
    114 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    115 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    116 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    117 Greater Regional Medical Center Creston Iowa United States 50801
    118 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    119 Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa United States 50309
    120 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    121 Broadlawns Medical Center Des Moines Iowa United States 50314
    122 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    123 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    124 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    125 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
    126 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    127 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    128 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    129 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    130 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    131 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    132 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    133 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    134 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    135 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
    136 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    137 Saint Joseph Hospital East Lexington Kentucky United States 40509
    138 Saint Joseph London London Kentucky United States 40741
    139 Jewish Hospital Louisville Kentucky United States 40202
    140 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
    141 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
    142 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
    143 Culicchia Neurological Clinic LLC Marrero Louisiana United States 70072
    144 West Jefferson Medical Center Marrero Louisiana United States 70072
    145 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    146 University Medical Center New Orleans New Orleans Louisiana United States 70112
    147 LSU Health Sciences Center at Shreveport Shreveport Louisiana United States 71103
    148 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan United States 48106
    149 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    150 Bronson Battle Creek Battle Creek Michigan United States 49017
    151 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
    152 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    153 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
    154 Saint Joseph Mercy Canton Canton Michigan United States 48188
    155 Caro Cancer Center Caro Michigan United States 48723
    156 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
    157 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    158 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
    159 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
    160 Ascension Saint John Hospital Detroit Michigan United States 48236
    161 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
    162 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    163 Genesee Hematology Oncology PC Flint Michigan United States 48503
    164 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    165 Hurley Medical Center Flint Michigan United States 48503
    166 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    167 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    168 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    169 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
    170 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
    171 Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan United States 48236
    172 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    173 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    174 Borgess Medical Center Kalamazoo Michigan United States 49048
    175 Sparrow Hospital Lansing Michigan United States 48912
    176 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    177 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
    178 Michigan Breast Specialists-Macomb Township Macomb Michigan United States 48044
    179 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
    180 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    181 Lakeland Hospital Niles Niles Michigan United States 49120
    182 Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan United States 49444
    183 Ascension Borgess Cancer Center Oshtemo Michigan United States 49008
    184 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
    185 Hope Cancer Center Pontiac Michigan United States 48341
    186 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
    187 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    188 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    189 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    190 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    191 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    192 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    193 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
    194 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    195 Munson Medical Center Traverse City Michigan United States 49684
    196 Advanced Breast Care Center PLLC Warren Michigan United States 48088
    197 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
    198 Macomb Hematology Oncology PC Warren Michigan United States 48093
    199 Michigan Breast Specialists-Warren Warren Michigan United States 48093
    200 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    201 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    202 Metro Health Hospital Wyoming Michigan United States 49519
    203 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
    204 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
    205 Riverwood Healthcare Center Aitkin Minnesota United States 56431
    206 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    207 Essentia Health Saint Joseph's Medical Center Brainerd Minnesota United States 56401
    208 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    209 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    210 Cambridge Medical Center Cambridge Minnesota United States 55008
    211 Mercy Hospital Coon Rapids Minnesota United States 55433
    212 Essentia Health - Deer River Clinic Deer River Minnesota United States 56636
    213 Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota United States 56501
    214 Essentia Health Cancer Center Duluth Minnesota United States 55805
    215 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
    216 Miller-Dwan Hospital Duluth Minnesota United States 55805
    217 Fairview Southdale Hospital Edina Minnesota United States 55435
    218 Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota United States 56537
    219 Essentia Health - Fosston Fosston Minnesota United States 56542
    220 Unity Hospital Fridley Minnesota United States 55432
    221 Essentia Health Hibbing Clinic Hibbing Minnesota United States 55746
    222 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    223 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    224 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    225 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    226 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    227 Health Partners Inc Minneapolis Minnesota United States 55454
    228 Monticello Cancer Center Monticello Minnesota United States 55362
    229 New Ulm Medical Center New Ulm Minnesota United States 56073
    230 Essentia Health - Park Rapids Park Rapids Minnesota United States 56470
    231 Fairview Northland Medical Center Princeton Minnesota United States 55371
    232 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    233 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    234 Regions Hospital Saint Paul Minnesota United States 55101
    235 United Hospital Saint Paul Minnesota United States 55102
    236 Essentia Health Sandstone Sandstone Minnesota United States 55072
    237 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    238 Lakeview Hospital Stillwater Minnesota United States 55082
    239 Sanford Thief River Falls Medical Center Thief River Falls Minnesota United States 56701
    240 Essentia Health Virginia Clinic Virginia Minnesota United States 55792
    241 Ridgeview Medical Center Waconia Minnesota United States 55387
    242 Rice Memorial Hospital Willmar Minnesota United States 56201
    243 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    244 Sanford Cancer Center Worthington Worthington Minnesota United States 56187
    245 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    246 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    247 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    248 Cox Cancer Center Branson Branson Missouri United States 65616
    249 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    250 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    251 Parkland Health Center - Farmington Farmington Missouri United States 63640
    252 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    253 Freeman Health System Joplin Missouri United States 64804
    254 Mercy Hospital Joplin Joplin Missouri United States 64804
    255 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    256 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    257 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    258 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    259 Mercy Hospital South Saint Louis Missouri United States 63128
    260 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    261 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    262 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    263 Mercy Hospital Springfield Springfield Missouri United States 65804
    264 CoxHealth South Hospital Springfield Missouri United States 65807
    265 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    266 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    267 Mercy Hospital Washington Washington Missouri United States 63090
    268 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    269 Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska United States 68803
    270 CHI Health Good Samaritan Kearney Nebraska United States 68847
    271 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
    272 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    273 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    274 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    275 Creighton University Medical Center Omaha Nebraska United States 68131
    276 Midlands Community Hospital Papillion Nebraska United States 68046
    277 AtlantiCare Health Park-Cape May Court House Cape May Court House New Jersey United States 08210
    278 AtlantiCare Surgery Center Egg Harbor Township New Jersey United States 08234
    279 Lovelace Medical Center-Downtown Albuquerque New Mexico United States 87102
    280 Lovelace Medical Center-Saint Joseph Square Albuquerque New Mexico United States 87102
    281 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    282 Lovelace Radiation Oncology Albuquerque New Mexico United States 87109
    283 Northwell Health Imbert Cancer Center Bay Shore New York United States 11706
    284 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    285 Cone Health Cancer Center at Asheboro Asheboro North Carolina United States 27203
    286 Randolph Hospital Asheboro North Carolina United States 27203
    287 Mission Hospital Asheville North Carolina United States 28801
    288 Cone Health Cancer Center at Alamance Regional Burlington North Carolina United States 27215
    289 Wake Forest University at Clemmons Clemmons North Carolina United States 27012
    290 Central Carolina Surgery Greensboro North Carolina United States 27401
    291 Cone Health Cancer Center Greensboro North Carolina United States 27403
    292 Novant Health Breast Surgery - Greensboro Greensboro North Carolina United States 27403
    293 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    294 Novant Health Cancer Institute - Kernersville Kernersville North Carolina United States 27284
    295 Cone Heath Cancer Center at Mebane Mebane North Carolina United States 27302
    296 Novant Health Cancer Institute - Mount Airy Mount Airy North Carolina United States 27030
    297 Annie Penn Memorial Hospital Reidsville North Carolina United States 27320
    298 Novant Health Cancer Institute - Statesville Statesville North Carolina United States 28625
    299 Novant Health Cancer Institute - Thomasville Thomasville North Carolina United States 27360
    300 Novant Health Cancer Institute - Wilkesboro Wilkesboro North Carolina United States 28659
    301 Wake Forest Baptist Health - Wilkes Medical Center Wilkesboro North Carolina United States 28659
    302 Novant Health Forsyth Medical Center Winston-Salem North Carolina United States 27103
    303 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    304 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    305 Essentia Health Cancer Center-South University Clinic Fargo North Dakota United States 58103
    306 Sanford South University Medical Center Fargo North Dakota United States 58103
    307 Southpointe-Sanford Medical Center Fargo Fargo North Dakota United States 58103
    308 Sanford Medical Center Fargo Fargo North Dakota United States 58104
    309 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    310 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    311 Essentia Health - Jamestown Clinic Jamestown North Dakota United States 58401
    312 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    313 Adena Regional Medical Center Chillicothe Ohio United States 45601
    314 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    315 Bethesda North Hospital Cincinnati Ohio United States 45242
    316 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    317 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    318 Mount Carmel East Hospital Columbus Ohio United States 43213
    319 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    320 Riverside Methodist Hospital Columbus Ohio United States 43214
    321 Grant Medical Center Columbus Ohio United States 43215
    322 The Mark H Zangmeister Center Columbus Ohio United States 43219
    323 Mount Carmel Health Center West Columbus Ohio United States 43222
    324 Doctors Hospital Columbus Ohio United States 43228
    325 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    326 Grady Memorial Hospital Delaware Ohio United States 43015
    327 Columbus Oncology and Hematology Associates Dublin Ohio United States 43016
    328 Dublin Methodist Hospital Dublin Ohio United States 43016
    329 Central Ohio Breast and Endocrine Surgery Gahanna Ohio United States 43230
    330 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
    331 Fairfield Medical Center Lancaster Ohio United States 43130
    332 Saint Rita's Medical Center Lima Ohio United States 45801
    333 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    334 Marietta Memorial Hospital Marietta Ohio United States 45750
    335 OhioHealth Marion General Hospital Marion Ohio United States 43302
    336 Knox Community Hospital Mount Vernon Ohio United States 43050
    337 Licking Memorial Hospital Newark Ohio United States 43055
    338 Newark Radiation Oncology Newark Ohio United States 43055
    339 Mercy Health - Perrysburg Hospital Perrysburg Ohio United States 43551
    340 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    341 Mercy Health - Saint Vincent Hospital Toledo Ohio United States 43608
    342 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    343 Mercy Health Sylvania Radiation Oncology Center Toledo Ohio United States 43623
    344 Saint Ann's Hospital Westerville Ohio United States 43081
    345 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    346 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    347 Saint Charles Health System Bend Oregon United States 97701
    348 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    349 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    350 Bay Area Hospital Coos Bay Oregon United States 97420
    351 Providence Newberg Medical Center Newberg Oregon United States 97132
    352 Providence Portland Medical Center Portland Oregon United States 97213
    353 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    354 Saint Charles Health System-Redmond Redmond Oregon United States 97756
    355 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
    356 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    357 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    358 Geisinger Medical Center Danville Pennsylvania United States 17822
    359 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
    360 Lehigh Valley Hospital-Hazelton Hazleton Pennsylvania United States 18201
    361 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    362 Paoli Memorial Hospital Paoli Pennsylvania United States 19301
    363 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    364 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    365 Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina United States 29910
    366 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    367 Medical University of South Carolina Charleston South Carolina United States 29425
    368 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    369 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    370 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    371 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
    372 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    373 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    374 South Carolina Cancer Specialists PC Hilton Head Island South Carolina United States 29926-3827
    375 The Radiation Oncology Center-Hilton Head/Bluffton Hilton Head Island South Carolina United States 29926
    376 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    377 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    378 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    379 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    380 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    381 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    382 Saint Michael Cancer Center Bremerton Washington United States 98310
    383 Highline Medical Center-Main Campus Burien Washington United States 98166
    384 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    385 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    386 Saint Elizabeth Hospital Enumclaw Washington United States 98022
    387 Providence Regional Cancer Partnership Everett Washington United States 98201
    388 Saint Francis Hospital Federal Way Washington United States 98003
    389 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    390 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    391 Saint Clare Hospital Lakewood Washington United States 98499
    392 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    393 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    394 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    395 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
    396 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    397 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    398 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    399 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    400 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    401 Aspirus Langlade Hospital Antigo Wisconsin United States 54409
    402 Duluth Clinic Ashland Ashland Wisconsin United States 54806
    403 Northwest Wisconsin Cancer Center Ashland Wisconsin United States 54806
    404 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    405 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    406 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    407 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
    408 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    409 Aspirus Medford Hospital Medford Wisconsin United States 54451
    410 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    411 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    412 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    413 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    414 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    415 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    416 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    417 Diagnostic and Treatment Center Weston Wisconsin United States 54476
    418 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    419 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
    420 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    421 FHP Health Center-Guam Tamuning Guam 96913

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Michael D Chan, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03475186
    Other Study ID Numbers:
    • IRB00053531
    • 3UG1CA189824-04S1
    • NCI-2018-01807
    • WF-1801
    • NCI-2018-01807
    First Posted:
    Mar 23, 2018
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Wake Forest University Health Sciences
    Memory
    Brain Cancer
    Ramipril
    Additional relevant MeSH terms:
    Glioblastoma
    Cognitive Dysfunction
    Ramipril

    Study Results

    No Results Posted as of Apr 29, 2022