Fosaprepitant for N/V With High-dose Interleukin-2 for Metastatic Melanoma and Renal Cell Carcinoma
Status:
Terminated
Trial end date:
2015-12-03
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate the effectiveness of intravenous fosaprepitant
therapy to reduce nausea and vomiting during the treatment of high dose interleukin-2 (HD
IL-2) therapy for metastatic melanoma or metastatic renal cell carcinoma. Fosaprepitant is an
intravenous (IV) medication that is FDA- approved for use in adults for the prevention of
nausea and vomiting during chemotherapy. Fosaprepitant works by blocking the neurokinin-1
receptor, which is a receptor in the brain that is known to cause nausea and vomiting. Past
studies estimate that up to 70% of patients undergoing treatment with HD IL-2 will have
nausea and/or vomiting. While fosaprepitant has been used in clinical practice to treat
nausea and vomiting during HD IL-2, there have not been any studies done to see how well it
works. All patients will receive treatment (IV fosaprepitant) during the study during either
the first or second hospital admission for HD IL-2. On the admission that the subject is not
receiving IV fosaprepitant, the subject will receive placebo (a medicine that looks like
fosaprepitant, but is not active). The study is double-blinded, which means neither the
subject, nor the study doctor will know to which group you have been assigned to that
admission (IV fosaprepitant or placebo). This study design was chosen to limit the potential
for bias, which means the trial was designed to try to ensure that unknown factors do not
affect trial results. When patients start the study, patients will be randomly assigned to
one of two groups: those who receive treatment (IV fosaprepitant) first and those who receive
placebo first. During the first admission, subjects will be given the IV fosaprepitant or IV
placebo during admission. During the second admission, subjects will 'crossover' and receive
the other treatment that they did not receive during the first admission. Improvement in
nausea and vomiting will be assessed by counting the number of nausea and vomiting episodes,
recording if the subject needs additional medication for nausea and vomiting, and by using
patient questionnaires.