Experimental lung inflammation treatment trial shuts down after just one patient
NCT ID NCT04438382
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This phase 2 trial aimed to see if infliximab and intravenous immunoglobulin (IVIG) could help cancer patients with severe lung inflammation that didn't respond to steroids. Only one patient was enrolled before the study was terminated, so no meaningful results were obtained. The approach remains unproven.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- infliximab and intravenous immunoglobulin (IVIG)
- What this could lead to
- If it had succeeded, this could have pointed toward a better treatment for severe lung inflammation caused by immunotherapy in cancer patients.
- What could go wrong
- The trial was terminated early with only one participant, so no reliable conclusions can be drawn. The approach may not work or may have risks like infection or allergic reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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1 person
The number who actually took part.
- Started
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Jan 2021
- Finished
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Dec 2023
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be English-speaking and be able to provide informed consent * Patient must be willing and able to undergo arterial blood gas assessment as per the treating investigator. Patient must not have contraindication for arterial blood gas assessment * Women must not be pregnant or breast-feeding due to the potential risk to the fetus of infliximab or IVIG. All females of childbearing potential must have a blood test or urine test within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method(s) of contraception or to abstain from sexual intercourse for a minimum of 56 days (the duration of their participation in the study) * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 * Patient may have received any number of lines of prior systemic therapy * Patient may have any solid tumor or hematologic malignancy is eligible * Patient must have received treatment with an anti-PD-1/PD-L1 agent either alone or in combination with another anti-cancer agent, as their most recent therapy prior to development of pneumonitis * Patient must have steroid-refractory pneumonitis defined as: * Grade 2 pneumonitis that has not clinically improved by a Common Terminology Criteria for Adverse Events (CTCAE) grade in greater than 72 hours or maximum of 14 days or * Grade 3 or higher pneumonitis that has not clinically improved by a CTCAE grade in greater than 48 hours or maximum of 14 days with high dose corticosteroids (methylprednisolone or prednisone 1-4 mg/kg/equivalent) as their most recent treatment for pneumonitis, as determined by the treating investigator * Patient may have received anti-PD-1/PD-L1 therapy as standard-of-care or part of a clinical trial * Patient must have had pathogen-negative infectious diagnostic evaluation within 14 days prior to randomization, and at a minimum these should include: blood culture, urine culture, sputum culture, and viral panel: rapid flu, respiratory syncytial virus (RSV), herpes simplex virus (HSV). Empiric antibiotics for culture negative infections are not an exclusion for study entry * Patient must have had a pathogen-negative bronchoscopic assessment of BAL fluid within 14 days prior to randomization. A minimum assessment for pathogens on BAL must include: gram stain, fungal panel, viral panel * Patient must have a negative tuberculosis assessment (TB spot test, quantiferon gold or tuberculin skin test) within 14 days prior to randomization * Patient must have chest computed tomography (CT) scan without contrast performed =\< 14 days before randomization. Patient must not have a contraindication for CT Exclusion Criteria: * Patient must not have clinical evidence of cardiac dysfunction (as determined by the treating investigator) as an alternative diagnosis to steroid-refractory pneumonitis * Patient must not be receiving anti-PD-1/-PD-L1 agent in combination with any of the following anti-cancer agents: docetaxel, cyclophosphamide, gefitinib, erlotinib, osimertinib, crizotinib, bleomycin, afatinib * Patient must not be receiving concurrent radiation therapy to the chest * Patient must not be deemed to have radiation pneumonitis. Patients with a history of stable radiation pneumonitis not requiring corticosteroid therapy within the last 3 months prior to randomization will be allowed on study * Patient must not have pre-existing interstitial lung disease or pneumonitis requiring corticosteroid therapy from any other cause, as determined by the treating investigator * Patient must not have an absolute contraindication to IVIG or infliximab, including: clinical history of severe hypersensitivity reaction, selective IgA deficiency, active hepatitis B, active tuberculosis, active human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) where a study subject has a CD4 count of =\< 200 at screening, or drug interaction
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
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Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
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Lakeland Hospital Niles
Niles, Michigan, 49120, United States
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Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
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Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
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Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
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Metro Health Hospital
Wyoming, Michigan, 49519, United States
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Munson Medical Center
Traverse City, Michigan, 49684, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
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Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
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VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
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Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
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West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
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