For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.
Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.
Listing- ClinicalTrial.gov- NCT02293005
Official Title- Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma
Sponsor- M.D. Anderson Cancer Center
Millennium Pharmaceuticals Inc.
Location- M.D. Anderson Cancer Center Houston Texas
Principle Investigator- Anne S. Tsao M.D. M.D. Cancer Center
Contact-Anne S. Tsao M.D.- 713- 792-6363
Purpose- To find out if a drug named Alisertib can help control mesothelioma. This is a study investigating the safety of the drug and if it helps in the control of mesothelioma. Alisertib is a drug that targets a protein called aurora A kinase in cancer cells. Alisertib is an inhibitor it is hoped it will target aurora A kinase and kill cancer cells.
Screening– – Lab blood tests- must have an Absolute Neutrophil count (ANC) >1500/mm3, platelets > 100,000mm3, Hgb >9g/dl
Liver function tests – total billirubin <= 1.5 of upper limit of normal etc.
Pathological diagnosis of malignant mesothelioma
Eligibility Criteria– – Voluntary informed consent
- Must be 18 or older
- Must have measurable disease by modified RECIST or RECIST. Examination for measurable disease completed within 28 days prior to registration
- Up to 4 prior lines of systemic therapy (biological or chemotherapy) are allowed
- Received at least one prior pemetrexed-based chemotherapy for unrespectable disease, unless within 3 months of receiving platinum pemetrexed therapy for neoadjuvant or adjuvant treatment that has been unsuccessful
- Have unresectable malignant mesothelioma- any histology
- Diagnosis of malignant mesothelioma- any primary site
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate renal function as defined by: Calculated creatine clearance must be >/= 30 ml/
– Females- either post-menopausal for at least one year before the screening visit- or surgically sterilized, or willing to use an acceptable method of birth control- for the length of the study and at least 1 month after the last dose of alisertib.
- Male even if surgically sterilized, agrees to use an acceptable barrier method for contraception, or completely abstain from heterosexual intercourse during the entire study treatment period through 4 months after the last dose of alisertib
- Prior radiation therapy. Radiation therapy to more than 25% of the bone marrow.
- Prior allogeneic bone marrow or organ transplantation
- Known GI disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib.
- Known history of uncontrolled sleep apneas syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease. Patients who use CPCAP or BIPAP at night and have controlled sleep apnea syndrome are allowed.
- Requirement for constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids or H2 antagonists are allowed.
- Systemic infection requiring IV antibiotic therapy within 14 days preceding the first dose of study drug or other severe infection.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III of IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Female subject who is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Treatment with clinically significant enzyme inducers, such as enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St John’s wort within 14 days prior to the first dose of alisertib and during the study.
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion. For guidance in defining active infection for hepatitis B, please refer to the WHO guidelines.
- Prior administration of an Aurora A kinase-targeted agent, including alisertib.
- Receipt of corticosteroids within 7 days prior to the first dose of study treatment, unless patient has been taking a continuous dose of no more that 15mg/day of prednisone for at least 1 month prior to the first dose of study treatment. Low dose steroid use for the control of nausea and vomiting will be allowed. Topical steroid use is permitted. Inhaled steroids are permitted.
- Inability to swallow oral medication or inability or unwillingness to comply with the administration requirements related to alisertib.
- Administration of myeloid growth factors or platelet transfusion within 14 days prior to the first dose of study treatment.
- Persons who are incarcerated at time of enrollment (e.g. prisoners) or likely to become incarcerated during the study.
How the Research Study is Designed to Work
The drug Alisertib is taken by mouth twice a day for 7 days in each treatment cycle which is 3 weeks long. After taking the medication for 7 days they do not take the medicine for the next 14 days. The participant is followed by physical exams, blood draws, and every 6 weeks while on the study PET-CT scan of the chest, abdomen, and pelvis to check the status of the disease.
The hope of the researcher is to assess 4- month disease control rate in pre-treated patients that have malignant pleural mesothelioma treated with alisertib
With any clinical trial all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.
Please do not hesitate to contact us with any questions.