Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pn… (NCT04438382) | Clinical Trial Compass
TerminatedPhase 2
Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
Stopped: Slow accrual
United States1 participantsStarted 2021-01-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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/P…