Everolimus Therapy in People With Birt-Hogg-Dube Syndrome (BHD)-Associated Kidney Cancer or Sporadic Chromophobe Renal Cancer

Stopped early · Phase 2

Conditions studied: Renal Cancer, Birt-Hogg-Dube Syndrome

In brief

Background: \- Research has shown that the drug everolimus can stop cancer cells from growing. It is approved for people with advanced kidney cancer. Researchers want to see if it also helps people with two other types of kidney cancer. Objective: \- To see if everolimus is safe and effective in people with Birt-Hogg-Dube Syndrome (BHD)-associated kidney cancer or sporadic (nonfamilial) chromophobe renal cancer. Eligibility: \- People ages 18 and over with BHD-associated kidney cancer or advanced sporadic chromophobe renal cancer. Design: * Participants will be screened with: * Medical history, physical exam, and blood and urine tests. * Computed tomography (CT) scan or magnetic resonance imaging (MRI) scan. They will lie in a machine that takes pictures of their chest/abdomen/pelvis. * They may also be screened with: * Another scan, of the brain or neck. * Bone scan. * Positron emission tomography scan with fludeoxyglucose (FDG-PET). * Heart and lung tests. * Tests for hepatitis. * Participants will take a tablet once a day by mouth for up to a year. They will keep a diary of when they take the tablet and any symptoms. * During the study, participants will have physical exams and urine and blood tests. They will have scans of the chest/abdomen/pelvis. They may have FDG-PET and bone scans. * Participants will have tests for hepatitis and may have a tumor sample taken. * Participants will have a follow-up visit 4-5 weeks finishing taking the drug. They will have a physical exam and blood tests. They may have scans and/or hepatitis tests. * Participants will be called about every 3-6 months after the study ends to see how they are doing

Key facts

Study ID: NCT02504892
Run by: National Cancer Institute (NCI)
People needed: 3
Starts: 2015-07-21
Expected to finish: 2018-04-17
Last updated by the study team: 2019-03-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients currently receiving anticancer therapies (including chemotherapy, radiation therapy, antibody based therapy, etc.).
Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus).
Patients with known brain metastases unless treated with an appropriate modality with no evidence of progression/recurrence for >3months
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, invasive fungal infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with everolimus. Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus.
Uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) >8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary.
Patients who have any severe and/or uncontrolled medical conditions such as:
unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction less than or equal to 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease.
Symptomatic congestive heart failure of New York heart Association Class III or IV.
known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) 50% or less of normal and oxygen (O2) saturation 88% or less at rest on room air).
active, bleeding diathesis.
Chronic (treatment > 1 month) or ongoing treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed.
Patients who have received live attenuated vaccines within 1 week of start of everolimus Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guerin (BCG), yellow fever, varicella and typhoid vaccine) TY21a typhoid vaccines.
Patients, who in the opinion of the investigator, are unlikely to comply with follow-up visits or other study requirements. Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing.
Pregnant or nursing (lactating) women.
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, who do not agree to use highly effective methods of contraception during the study and 8 weeks after.
Highly effective contraception methods include combination of any two of the following:
Use of oral, injected or implanted hormonal methods of contraception or;
Placement of an intrauterine device (IUD) or intrauterine system (IUS);
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
Total abstinence or;
Male/female sterilization.
Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment.
Prior invasive malignancy of other histology currently requiring treatment.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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