Clinical Trials Directory

Trials / Terminated

TerminatedNCT04438382

Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis

Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
1 (actual)
Sponsor
ECOG-ACRIN Cancer Research Group · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well infliximab and intravenous immunoglobulin therapy work in treating patients with pneumonitis that does not respond to steroid treatment. Immunotherapy with monoclonal antibodies such as, infliximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Intravenous immunoglobulin therapy may improve pneumonitis. It is not yet known whether giving infliximab and intravenous immunoglobulin therapy will work better in treating patients with pneumonitis.

Detailed description

PRIMARY OBJECTIVE: I. To assess pneumonitis response to additional immunosuppression (infliximab or intravenous immunoglobulin therapy \[IVIG\]) in patients with steroid-refractory pneumonitis at 28-days. SECONDARY OBJECTIVES: I. To assess functional parameters of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG). II. To assess radiologic parameters of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG). III. To assess patient-reported outcomes of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG). IV. To assess death after additional immunosuppression. V. To assess the rate of infections in the 28-day period after additional immunosuppression. EXPLORATORY OBJECTIVES: I. To examine lung tissue, bronchoalveolar lavage (BAL) and serial blood samples in patients who develop steroid-refractory pneumonitis. II. To examine associations between BAL phenotypes and pneumonitis response, functional and radiologic parameters of pneumonitis. III. To evaluate associations between pneumonitis and autoantibodies, T-cell expansion, and baseline cytokines in the blood. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive infliximab intravenously (IV) on day 1 followed by prednisone taper IV or orally (PO) for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive an additional dose of infliximab IV on day 14 at the discretion of the treating physician. ARM B: Patients receive intravenous immunoglobulin therapy IV over 2-5 days per institutional guidelines followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28, 42 and 56 days.

Conditions

Interventions

TypeNameDescription
BIOLOGICALInfliximabGiven IV
BIOLOGICALIntravenous Immunoglobulin TherapyGiven IV
DRUGPrednisoneGiven IV or PO
DRUGMethylprednisoloneGiven IV or PO

Timeline

Start date
2021-01-07
Primary completion
2023-12-21
Completion
2023-12-21
First posted
2020-06-18
Last updated
2026-04-02
Results posted
2024-03-26

Locations

18 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04438382. Inclusion in this directory is not an endorsement.