Pasireotide in Reducing Gastrointestinal Toxicity from Chemotherapy and Radiation Therapy in Patients Undergoing a Donor Stem Cell Transplant

Inclusion Criteria

• Histologically confirmed diagnosis for which an allogeneic transplant is utilized
• Plan to receive an allogenic transplant from a 4-6/6 single or dual umbilical cord blood graft, or a 7-8/8 human leukocyte antigen (HLA)-matched sibling or unrelated donor (high resolution HLA-A, B, C, DRB1)
• Meet standard criteria as defined by the institution for a myeloablative allogeneic stem cell transplantation, with myeloablative defined as using conditioning regimens containing: * Total-body irradiation (TBI) >= 1200 cGy, or * Busulfan >= 12.8 mg/kg
• Patient must have given written informed consent according to Food and Drug Administration (FDA) guidelines
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures

Exclusion Criteria

• Female patients who are pregnant or lactating, or are of childbearing potential (FCBP, defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control * FCBP must have a current negative serum pregnancy test prior to transplant per institutional practice
• Use of an investigational drug within 1 month prior to dosing
• Concurrent enrollment on other clinical research studies that contain an interventional therapy is not permitted while subjects are receiving pasireotide or within 5 half lives of finishing pasireotide; however, subjects may concurrently enroll in non-interventional studies (e.g. biobanking, mobile health tracking)
• Active central nervous system (CNS) disease (related to primary malignancy) at the time of enrollment
• Patients with existing grade 2 toxicities, except as approved by the investigator
• History of unexplained syncope or family history of idiopathic sudden death
• Sustained or clinically significant cardiac arrhythmias
• Risk factors for torsades de pointes such as: * Uncontrolled hypokalemia * Uncontrolled hypomagnesemia or hypermagnesemia * Cardiac failure (New York Heart Association class II or higher) * Clinically significant/symptomatic bradycardia (hear rate [HR] < 50), or high-grade atrioventricular (AV) block * Known diagnosis of QT prolongation (QTc >= 470) or family history of long QT syndrome * Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), human immunodeficiency virus [HIV], cirrhosis, uncontrolled hypothyroidism or cardiac failure * Concomitant medications known to prolong the QT interval during the same time as pasireotide is to be administered (unless approved by principal investigator [PI] and QTc < 470; standard transplant medications that are known to prolong the QT (e.g. azoles, ondansetron, etc.) are permitted but caution is advised and patients should be closely monitored)
• Uncontrolled diabetes at the time of cytoreduction; all patients with diabetes must be optimized on their diabetes regimen prior to initiating pasireotide * If a patient is diabetic: uncontrolled diabetes as defined by hemoglobin A1c (HbA1c) > 8%* despite adequate therapy
• Patients who are not biochemically euthyroid; patients with known history of hypothyroidism are eligible if they are on adequate and stable replacement thyroid hormone therapy for at least 3 months
• Known diagnosis of hypocortisolism
• Known diagnosis of pituitary hormone deficiency
• Known hypersensitivity to somatostatin analogs or any component of the pasireotide long acting release (LAR) or suspension concentrate (s.c.) formulations
• Uncontrolled (not being treated) infections at the time of cytoreduction
• A positive HIV test result (enzyme-linked immunosorbent assay [ELISA] and Western blot) or history of known HIV; an HIV test will not be required; however, previous medical history will be reviewed
• Moderately impaired hepatic function (Child-Pugh B) or severe hepatic impairment (Child-Pugh C)
• Known gallbladder or bile duct disease, symptomatic cholelithiasis, acute or chronic pancreatitis
• Known malabsorption syndrome, short bowel or chologenic diarrhea not controlled by specific therapeutic means
• Abnormal coagulation (partial thromboplastin [PT] or activated partial thromboplastin time [aPTT] > 30% above normal limits)
• Continuous anticoagulation therapy; patients who were on anticoagulant therapy must complete a washout period of at least 10 days and have confirmed normal coagulation parameters before study inclusion
• Major surgery/surgical therapy for any cause within 1 month prior to pasireotide administration; patients should have recovered and have a good clinical condition before entering the study
• Any co-morbid condition which, in the view of the principal investigator, renders the patient at high risk from treatment complications
• Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study