Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant
Condition: Malignant Neoplasm
MeSH terms: Neoplasms; Vomiting
Intervention: Netupitant; Palonosetron Hydrochloride; Questionnaire Administration
Intervention description: 300 mg, Given PO, QD; 0.5 mg, Given PO, QD; Ancillary studies
Intervention MeSH terms: Palonosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well netupitant and palonosetron hydrochloride work in
      preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing BEAM
      conditioning regimen before stem cell transplant. Chemotherapy, such as carmustine,
      cytarabine, etoposide, and melphalan (BEAM), makes people feel sick to their stomach and
      causes vomiting. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting
      caused by the BEAM treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be undergoing autologous or allogeneic hematopoietic stem cell
             transplant (HSCT) with the BEAM conditioning regimen prior to HSCT

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky
             Performance Score >= 60%

          -  Able to swallow oral medications

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Subjects with known hypersensitivity or other allergic reactions attributed to
             compounds of similar biologic composition to netupitant, palonosetron, dexamethasone,
             or other agents used in the study

          -  Subjects who are receiving any other investigational agents or have received another
             investigational drug in the last 30 days

          -  Subjects who have had emesis or required antiemetics in the 48 hours prior to starting
             the BEAM conditioning regimen; patients required to take antipsychotics, appetite
             stimulants, or other medications with antiemetic effects will also be excluded if
             those medications cannot be replaced by therapeutic equivalents

          -  Female subjects who are pregnant, have a positive serum human chorionic gonadotrophin
             (hCG), or are lactating and intend to breastfeed a child; pregnant women are excluded
             from this study; breastfeeding should be discontinued if the mother is treated with
             NEPA

          -  Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral
             therapy are ineligible

          -  Subjects who have taken a neurokinin antagonist within 14 days prior to beginning the
             BEAM regimen

          -  Subjects who have a serum creatinine > 2 x upper limit of normal (ULN)

          -  Subjects with severe renal failure or end stage renal disease (estimated GFR
             [glomerular filtration rate] of < 30 mL/min) as estimated by the Cockcroft-Gault
             formula

          -  Subjects with severe hepatic insufficiency (Child Pugh score > 9)

          -  Subjects who have been reported > 5 alcoholic drinks daily for the last year

          -  Subjects who have concurrent illness requiring systemic corticosteroid use other than
             the planned dexamethasone during conditioning therapy

          -  Subjects with gastrointestinal conditions that might result in malabsorption of the
             study drug

          -  Subjects with a history of anxiety-induced ("anticipatory") nausea and vomiting

          -  Subjects on strong CYP 3A4 inducers or inhibitors who are unable to have those agents
             replaced with clinical alternatives prior to beginning the study; length of washout
             period will be 7 days; notably, in the case of allogeneic transplant recipients
             requiring cyclosporine or tacrolimus, no empiric dose adjustments will be required due
             to close level monitoring and adjustments, that are standard in Oregon Health &
             Science University (OHSU) protocols

          -  Subjects unable to discontinue benzodiazepines as antiemetics will not be allowed;
             additional antiemetics will be allowed for rescue but not for prophylaxis

          -  Subjects with personal or family history of QT prolongation, uncorrected electrolyte
             abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and
             those taking antiarrhythmic medicinal products or other medicinal products that lead
             to QT prolongation or electrolyte abnormalities; relevant information will be
             collected as part of subject medical history