Clinical trial NCT02755233: Ipilimumab-induced Lung Toxicity: Observational Study
Official title: Ipilimumab-induced Lung Toxicity: A Prospective Observational Study on Pulmonary Function Changes in Patients With Metastatic Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Melanoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in whom a treatment with ipilimumab due to metastatic melanoma is indicated

Brief summary: Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM before and during treatment with ipilimumab are performed. A reduction from baseline of forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus indicative for pulmonary toxicity.

Detailed description: The aim of this prospective observational study is to determine the prevalence of ipilimumab lung toxicity defined by a significant decline of the diffusing capacity of the lung for carbon monoxide (DLCO) and/or forced vital capacity (FVC) in patients with MM.

Patients aged over 18 years with an established diagnosis of MM who are treated and followed up at the Department of Dermatology are asked to participate in the study after the indication for treatment with ipilimumab is given by the interdisciplinary skin tumorboard conference. After written informed consent is obtained, patients undergo a baseline evaluation (V1) including a medical history, physical examination, laboratory analyses (hemoglobin, leucocytes count, C-reactive protein, and pulmonary function tests (PFTs) with spirometry and measurement of DLCO. Thereafter, the first dose of ipilimumab (3mg/kg) is given intravenously over a period of 90 minutes without premedication. The subsequent three doses of ipilimumab are administered three weekly with analogue dose. Subsequent study visits (V2, V3, V4) including PFTs are scheduled on the same day as ipilimumab is administered. Thus, study visits are thoroughly adapted to the clinical visits, which is given by the administration of ipilimumab (total of four injections each separated by three weeks). In case of new respiratory symptoms during the study period, additional PFTs and a high-resolution computed tomography (HR-CT) of the chest are performed. In case of early study termination during follow-up pulmonary function test values which are already obtained are used for the final analysis.

Eligibility criteria: Inclusion Criteria:

* Established diagnosis of metastatic melanoma

Exclusion Criteria:

* Acute pulmonary infection at enrolment

Primary outcomes:
measure: Relative reduction of DLCO of more than 15% from the baseline value during follow-up
timeFrame: 9 weeks
Secondary outcomes:
measure: Relative reduction of FVC of more than 10% from the baseline value during
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Pulmonology
Study officials:
affiliation: University Hospital Zurich, Divison of Pneumology
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
References: