Fosaprepitant for N/V With High-dose Interleukin-2 for Metastatic Melanoma and Renal Cell Carcinoma
| Status: | Terminated |
|---|---|
| Conditions: | Skin Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 6/9/2018 |
| Start Date: | September 2013 |
| End Date: | December 3, 2015 |
Phase 2B Double Blind Placebo Controlled Crossover Study Evaluating the Efficacy of IV Fosaprepitant for Chemo Induced N/V With High Dose Interleukin 2 for Metastatic Melanoma and Metastatic Renal Cell Carcinoma
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.
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.
This is a Phase 2B double-blind placebo-controlled crossover study evaluating the efficacy of
intravenous fosaprepitant for chemotherapy-induced nausea and vomiting in patients undergoing
high-dose interleukin-2 (HD IL-2) therapy (720,000 IU/kg per dose intravenously; 14 doses, 2
cycles per course) for metastatic melanoma and metastatic renal cell carcinoma. A total of 22
subjects will be enrolled in the study. On study entry, patients will be randomized to
receive either IV fosaprepitant (150 mg on Day 1, Day 3, or Day 5) or matched placebo during
first admission of HD IL-2 therapy (cycle 1). All subjects will crossover and receive the
opposite treatment during cycle 2. All patients will receive ondansetron 24 mg by mouth daily
per standard protocol every 24 hours during Days 1-5 of admission starting 30 minutes prior
to first dose of HD IL-2. During the treatment phase, subjects will receive Patients will
receive IV fosaprepitant 30 minutes before first dose of HD IL-2 therapy and every 48 hours
until completion of HD IL-2 therapy. Upon study entry, the subjects will be given a dairy to
report episodes of vomiting, use of rescue therapy, and nausea assessments using the 1-100
scale within the visual analogue scale (VAS). The subject will be instructed to complete
entries from baseline assessment (prior to first dose) until 5 days after last dose of HD
IL-2 for endpoint analysis. During inpatient admissions, subjects will complete diary entries
before each dose (q8 hours). As an outpatient, subjects will complete diary entries on a
daily basis. Recording of whether or not pruritus was observed will also be collected within
the subject diary. If a patient reports pruritus, the severity of pruritus on the 1-100 scale
visual analogue scale (VAS) will also be collected. The study team will record any episodes
of vomiting and the use of rescue therapy and ensure completion of patient diary during
inpatient portion. Assessments will be made via telephone contact to determine onset of any
episodes of CINV during outpatient portion. Safety assessments including adverse events (AEs)
monitoring will be performed and assessed using Common Terminology Criteria for Adverse
Events (CTCAE) version 4.0.
intravenous fosaprepitant for chemotherapy-induced nausea and vomiting in patients undergoing
high-dose interleukin-2 (HD IL-2) therapy (720,000 IU/kg per dose intravenously; 14 doses, 2
cycles per course) for metastatic melanoma and metastatic renal cell carcinoma. A total of 22
subjects will be enrolled in the study. On study entry, patients will be randomized to
receive either IV fosaprepitant (150 mg on Day 1, Day 3, or Day 5) or matched placebo during
first admission of HD IL-2 therapy (cycle 1). All subjects will crossover and receive the
opposite treatment during cycle 2. All patients will receive ondansetron 24 mg by mouth daily
per standard protocol every 24 hours during Days 1-5 of admission starting 30 minutes prior
to first dose of HD IL-2. During the treatment phase, subjects will receive Patients will
receive IV fosaprepitant 30 minutes before first dose of HD IL-2 therapy and every 48 hours
until completion of HD IL-2 therapy. Upon study entry, the subjects will be given a dairy to
report episodes of vomiting, use of rescue therapy, and nausea assessments using the 1-100
scale within the visual analogue scale (VAS). The subject will be instructed to complete
entries from baseline assessment (prior to first dose) until 5 days after last dose of HD
IL-2 for endpoint analysis. During inpatient admissions, subjects will complete diary entries
before each dose (q8 hours). As an outpatient, subjects will complete diary entries on a
daily basis. Recording of whether or not pruritus was observed will also be collected within
the subject diary. If a patient reports pruritus, the severity of pruritus on the 1-100 scale
visual analogue scale (VAS) will also be collected. The study team will record any episodes
of vomiting and the use of rescue therapy and ensure completion of patient diary during
inpatient portion. Assessments will be made via telephone contact to determine onset of any
episodes of CINV during outpatient portion. Safety assessments including adverse events (AEs)
monitoring will be performed and assessed using Common Terminology Criteria for Adverse
Events (CTCAE) version 4.0.
Inclusion Criteria:
- Subjects must meet all of the following inclusion criteria to be eligible for
enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating
that the subject (or legally acceptable representative) has been informed of all
pertinent aspects of the trial.
2. Subjects who are willing to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
3. Be at least 18 years of age at the time of informed consent.
4. Has a diagnosis of metastatic melanoma or metastatic renal cell carcinoma and who
will undergo high-dose interleukin-2 (HD IL-2) therapy
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
at Baseline/Day 1 visit. (See Appendix 6 on p. 51, ECOG Performance Status)
6. Female of reproductive potential must agree use non-hormonal methods to avoid
pregnancy during study participation and for 1 month after last dose of study
drug
Exclusion Criteria:
- Subjects presenting with any of the following will not be included in the study:
1. Women who are pregnant or lactating, or planning pregnancy
2. Women of childbearing potential who refuse to use non-hormonal methods to avoid
pregnancy
3. Known hypersensitivity to any component of fosaprepitant or aprepitant
4. Have taken pimozide or cisapride <4 weeks, cytochrome P450 3A4 inducers within 30
days, strong CYP3A4 inhibitors within 7 days, or antiemetics within 48 hours
prior to treatment initiation (See Appendix 7 on p. 52 for list of CYP3A4
inducers and strong CYP3A4 inhibitors)
5. Have evidence of clinically significant and unstable diseases or conditions such
as cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal,
endocrine, collagen-vascular, or gastrointestinal abnormalities that the
investigator thinks may interfere with study participation
6. Participation in other study using an investigational or experimental therapy or
procedure within 4 weeks or 5 half-lives (whichever is longer) before study entry
7. Subjects cannot participate in studies of other investigational or experimental
therapies or procedures at any time during their participation in this study.
8. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the subject inappropriate for entry into this study.
9. Subjects who are investigational site staff members or who are Sponsor employees
directly involved in the conduct of the trial.
10. A subject who, in the opinion of the investigator or sponsor, will be
uncooperative or unable to comply with study procedures.
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