Trametinib in Treating Patients With Epithelioid Hemangioendothelioma That Is Metastatic, Locally Advanced, or Cannot Be Removed by Surgery

Description

This phase II trial studies how well trametinib works in treating patients with epithelioid hemangioendothelioma that has spread to other places in the body, nearby tissue or lymph nodes, or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Start Date

April, 19 2017

Estimated Completion Date

December 2023

Interventions

  • Other: Questionnaire Administration
  • Other: Laboratory Biomarker Analysis
  • Drug: Trametinib

Study ID

National Cancer Institute (NCI) -- NCI-2017-00712

Status

Recruiting

Trial ID

NCT03148275

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

27

Sponsor

National Cancer Institute (NCI)

Inclusion Criteria

  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
  • baseline imaging must be obtained within 30 days of day 1 of study
  • Patients must have histologically confirmed epithelioid hemangioendothelioma which is metastatic or locally advanced (unresectable)
  • Patients must have evidence of disease progression per RECIST 1.1 prior to enrollment or have evidence of cancer-related pain requiring symptom management with narcotic analgesics
  • Patients previously untreated or treated with drug therapy for epithelioid hemangioendothelioma (EHE) are eligible
  • there is no limit on the number of prior regimens used to be eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 6 months
  • Able to swallow orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or small bowel
  • All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) grade =< 1 (except alopecia) at the time of enrollment
  • Absolute neutrophil count (ANC) >= 1 x 10^9/L
  • Hemoglobin >= 9 g/dL, patients may receive transfusion to meet criterion
  • Platelets >= 75 x 10^9/L
  • Albumin >= 2.5 g/dL
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
  • NOTE: patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN
  • Serum creatinine =< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) >= 50 mL/min OR 24-hour urine creatinine clearance >= 50 mL/min
  • Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal (LLN) by echocardiogram (ECHO) or multigated acquisition scan (MUGA)
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control
  • abstinence) prior to study entry, during the study participation, and for four months after the last dose of the drug women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Human immunodeficiency virus (HIV)-patients positive for human immunodeficiency virus (HIV) are NOT excluded from this study, however HIV-positive patients must meet the following criteria:
  • A stable regimen of highly active anti-retroviral therapy (HAART)
  • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based test

Exclusion Criteria

  • Prior systemic therapy with a MEK inhibitor
  • History of another malignancy
  • Exception: patients who have been disease-free for 3 years or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible
  • consult the Cancer Therapy Evaluation Program (CTEP) medical monitor if unsure whether second malignancies meet the requirements specified above
  • History of interstitial lung disease or pneumonitis requiring supplemental oxygen or treatment with oral or intravenously administered corticosteroids
  • Any major surgery, extensive radiotherapy, chemotherapy with delayed toxicity (e.g. doxorubicin), biologic therapy, or immunotherapy within 21 days prior to enrollment and/or daily or weekly chemotherapy (e.g. sunitinib, sorafenib and pazopanib) without the potential for delayed toxicity within 14 days prior to enrollment
  • Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter
  • with a minimum of 14 days from the last dose) preceding the first dose of trametinib and during the study
  • Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trametinib, or excipients or to dimethyl sulfoxide (DMSO)
  • Current use of a prohibited medication
  • the following medications or non-drug therapies are prohibited:
  • Other anti-cancer therapy while on study treatment
  • (note: megestrol [Megace] if used as an appetite stimulant is allowed)
  • Concurrent treatment with bisphosphonates is permitted
  • however, treatment must be initiated prior to the first dose of study therapy prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis
  • The concurrent use of all herbal supplements is prohibited during the study (including, but not limited to, St. John's wort, kava, ephedra [ma huang], ginkgo biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
  • History or current evidence/risk of retinal vein occlusion (RVO)
  • History or evidence of cardiovascular risk including any of the following:
  • LVEF < LLN (lower limit of normal range)
  • A QT interval corrected for heart rate using the Bazett's formula QTcB >= 480 msec
  • History or evidence of current clinically significant uncontrolled arrhythmias (exception: patients with controlled atrial fibrillation for > 30 days prior to randomization are eligible)
  • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization
  • History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system
  • Treatment-refractory hypertension defined as a blood pressure of systolic >140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy
  • Patients with intra-cardiac defibrillators
  • Known cardiac metastases
  • Known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection (patients with chronic or cleared HBV and HCV infection are eligible)
  • Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
  • The study drug must not be administered to pregnant women or nursing mothers
  • women of childbearing potential should be advised to avoid pregnancy and use effective methods of contraception men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception if a female patient or a female partner of a patient becomes pregnant while the patient receives trametinib, the potential hazard to the fetus should be explained to the patient and partner (as applicable)
  • Inability to comply with protocol-required procedures

Gender

All

Ages

15 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (60)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Edwin Choy 877-726-5130 None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Edwin Choy 877-726-5130 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Edwin Choy 877-726-5130 None
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Edwin Choy 877-726-5130 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Edwin Choy 877-726-5130 None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Edwin Choy 877-726-5130 None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Edwin Choy 877-726-5130 None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Edwin Choy 877-726-5130 None
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Edwin Choy 877-726-5130 None
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles Edwin Choy 877-726-5130 None
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles Edwin Choy 877-726-5130 None
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles Edwin Choy 877-726-5130 None
Montefiore Medical CenterEinstein Campus - The Bronx, New York 176.6 miles Joseph A Sparano 718-904-2730 aecc@aecom.yu.edu
Montefiore Medical CenterWeiler Hospital - The Bronx, New York 176.6 miles Joseph A Sparano 718-904-2730 aecc@aecom.yu.edu
Montefiore Medical CenterEinstein Campus - The Bronx, New York 176.6 miles Joseph A Sparano 718-904-2730 aecc@aecom.yu.edu
Montefiore Medical CenterWeiler Hospital - The Bronx, New York 176.6 miles Joseph A Sparano 718-904-2730 aecc@aecom.yu.edu
Montefiore Medical CenterEinstein Campus - The Bronx, New York 176.6 miles Joseph A Sparano 718-904-2730 aecc@aecom.yu.edu
Montefiore Medical CenterWeiler Hospital - The Bronx, New York 176.6 miles Joseph A Sparano 718-904-2730 aecc@aecom.yu.edu
Columbia UniversityHerbert Irving Cancer Center - New York, New York 181.2 miles Gary K Schwartz 212-639-7202 None
Columbia UniversityHerbert Irving Cancer Center - New York, New York 181.2 miles Gary K Schwartz 212-639-7202 None
Columbia UniversityHerbert Irving Cancer Center - New York, New York 181.2 miles Gary K Schwartz 212-639-7202 None
Johns Hopkins UniversitySidney Kimmel Cancer Center - Baltimore, Maryland 356.0 miles Christian F Meyer 410-955-8804 jhcccro@jhmi.edu
Johns Hopkins UniversitySidney Kimmel Cancer Center - Baltimore, Maryland 356.0 miles Christian F Meyer 410-955-8804 jhcccro@jhmi.edu
Johns Hopkins UniversitySidney Kimmel Cancer Center - Baltimore, Maryland 356.0 miles Christian F Meyer 410-955-8804 jhcccro@jhmi.edu
University of Pittsburgh Cancer Institute UPCI - Pittsburgh, Pennsylvania 477.2 miles Melissa A Burgess 412-692-2001 None
University of Pittsburgh Cancer Institute UPCI - Pittsburgh, Pennsylvania 477.2 miles Melissa A Burgess 412-692-2001 None
University of Pittsburgh Cancer Institute UPCI - Pittsburgh, Pennsylvania 477.2 miles Melissa A Burgess 412-692-2001 None
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Aaron T Gerds 866-223-8100 None
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Aaron T Gerds 866-223-8100 None
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles Aaron T Gerds 866-223-8100 None
Duke University Medical Center - Durham, North Carolina 609.0 miles James L Abbruzzese 888-275-3853 None
Duke University Medical Center - Durham, North Carolina 609.0 miles James L Abbruzzese 888-275-3853 None
Duke University Medical Center - Durham, North Carolina 609.0 miles James L Abbruzzese 888-275-3853 None
Ohio State University Comprehensive Cancer Center - Columbus, Ohio 641.8 miles Gabriel R Tinoco Suarez 888-823-5923 ctsucontact@westat.com
Ohio State University Comprehensive Cancer Center - Columbus, Ohio 641.8 miles Gabriel R Tinoco Suarez 888-823-5923 ctsucontact@westat.com
Ohio State University Comprehensive Cancer Center - Columbus, Ohio 641.8 miles Gabriel R Tinoco Suarez 888-823-5923 ctsucontact@westat.com
University of Michigan Comprehensive Cancer Center - Ann Arbor, Michigan 645.2 miles Scott M Schuetze 800-865-1125 None
University of Michigan Comprehensive Cancer Center - Ann Arbor, Michigan 645.2 miles Scott M Schuetze 800-865-1125 None
University of Michigan Comprehensive Cancer Center EDDOP - Ann Arbor, Michigan 645.2 miles Scott M Schuetze 800-865-1125 None
University of Michigan Comprehensive Cancer Center - Ann Arbor, Michigan 645.2 miles Scott M Schuetze 800-865-1125 None
University of Michigan Comprehensive Cancer Center EDDOP - Ann Arbor, Michigan 645.2 miles Scott M Schuetze 800-865-1125 None
University of Michigan Comprehensive Cancer Center EDDOP - Ann Arbor, Michigan 645.2 miles Scott M Schuetze 800-865-1125 None
Vanderbilt UniversityIngram Cancer Center - Nashville, Tennessee 944.2 miles Elizabeth J Davis 800-811-8480 None
Vanderbilt UniversityIngram Cancer Center - Nashville, Tennessee 944.2 miles Elizabeth J Davis 800-811-8480 None
Vanderbilt UniversityIngram Cancer Center - Nashville, Tennessee 944.2 miles Elizabeth J Davis 800-811-8480 None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Brian A Van Tine 800-600-3606 info@siteman.wustl.edu
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Brian A Van Tine 800-600-3606 info@siteman.wustl.edu
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Brian A Van Tine 800-600-3606 info@siteman.wustl.edu
Siteman Cancer Center at West County Hospital - Creve Coeur, Missouri 1,048.4 miles Brian A Van Tine 800-600-3606 info@siteman.wustl.edu
Siteman Cancer Center at West County Hospital - Creve Coeur, Missouri 1,048.4 miles Brian A Van Tine 800-600-3606 info@siteman.wustl.edu
Siteman Cancer Center at West County Hospital - Creve Coeur, Missouri 1,048.4 miles Brian A Van Tine 800-600-3606 info@siteman.wustl.edu
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles Victor M Villalobos 720-848-0650 None
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles Victor M Villalobos 720-848-0650 None
University of Colorado Hospital - Aurora, Colorado 1,759.8 miles Victor M Villalobos 720-848-0650 None
Huntsman Cancer InstituteUniversity of Utah - Salt Lake City, Utah 2,094.1 miles Jonathan Whisenant 801-581-4477 clinical.trials@hci.utah.edu
Huntsman Cancer InstituteUniversity of Utah - Salt Lake City, Utah 2,094.1 miles Jonathan Whisenant 801-581-4477 clinical.trials@hci.utah.edu
Huntsman Cancer InstituteUniversity of Utah - Salt Lake City, Utah 2,094.1 miles Jonathan Whisenant 801-581-4477 clinical.trials@hci.utah.edu
Stanford Cancer Institute Palo Alto - Palo Alto, California 2,694.6 miles Kristen N Ganjoo 650-498-7061 ccto-office@stanford.edu
Stanford Cancer Institute Palo Alto - Palo Alto, California 2,694.6 miles Kristen N Ganjoo 650-498-7061 ccto-office@stanford.edu
Stanford Cancer Institute Palo Alto - Palo Alto, California 2,694.6 miles Kristen N Ganjoo 650-498-7061 ccto-office@stanford.edu

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