Ipilimumab-induced Lung Toxicity: Observational Study

NCT02755233 | Completed

• 1 other identifier: 2013-0191
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Relative reduction of DLCO of more than 15% from the baseline value during follow-up

  A relative reduction of ≥15% from baseline of DLCO was chosen as clinically meaningful, thus indicative of a possible interstitial lung disease as a consequence of ipilimumab induced pulmonary toxicity

  9 weeks

Secondary Outcomes (1)

• Relative reduction of FVC of more than 10% from the baseline value during

  9 weeks

Study Arms (1)

Pulmonary function

Patients in whom treatment with ipilimumab due to metastatic melanoma is indicated

Other: Pulmonary Function

Interventions

Pulmonary Function OTHER

Spirometry and DLCO were measured according to performance standards based on the statements from the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Values of DLCO were adjusted for the patient's current hemoglobin value, and the patients were asked to withhold cigarette smoking at least four hours before pulmonary function testing. Lung volumes and DLCO were measured with a commercial ZAN300 CO Diffusion system (nSpire Health GmbH, Oberthulba, Germany)

Also known as: Spirometry and CO-diffusion capacity measurement

Pulmonary function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in whom a treatment with ipilimumab due to metastatic melanoma is indicated

You may qualify if:

• Established diagnosis of metastatic melanoma

You may not qualify if:

• Acute pulmonary infection at enrolment

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Pulmonology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel Franzen, MD

  University Hospital Zurich, Divison of Pneumology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 28, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)