Many people develop joint pain, stiffness and swelling due to their cancer treatment that targets the immune system. The severity of symptoms ranges from mild to debilitating and sometimes requires delaying or stopping cancer treatment. The usual plan is to discontinue cancer treatment and give relatively high doses of a medication called prednisone (a steroid, which is an anti-inflammatory medication which may suppress the immune system), with a gradual lowering of the dose over several weeks. While this can be effective, prednisone can cause several side effects, and it is not known if this is the best or safest treatment. Hydroxychloroquine is a medication being studied on IMPACT 2.0 on participants who develop inflammatory joint pain while taking cancer treatments that affect their immune system. It is possible that the hydroxychloroquine treatment may not work well on some participants on IMPACT 2.0. Hydroxychloroquine is also given as standard of care to participants with this type of inflammatory joint pain. The goal of this study is to learn how well methotrexate is at treating inflammatory joint pain in participants from IMPACT 2.0 that don't do well on treatment with hydroxychloroquine and in patients given hydroxychloroquine as standard of care to treat this type of inflammatory joint pain caused by taking cancer treatments which target their immune system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Methotrexate 20 mg PO weekly
Cross Cancer Institute
Edmonton, Canada
Discontinuation of Prednisone
Proportion of patients who were able to discontinue prednisone by 12 weeks without recurrence of grade 2 or higher irAA.
Time frame: 12 weeks
Total Steroid Usage
The total cumulative dose of prednisone measured in mg used by the participant. If corticosteroids other than prednisone are used, their equivalent dosage in mg of prednisone will be calculated and used for this analysis.
Time frame: 12 weeks
Development of Immune Related Adverse Events (irAEs) Other Than irAA
Defined as the emergence of adverse events that were not present at study baseline that are deemed by the investigator to be related to prior use of immune checkpoint inhibitors. Causality will be investigator assessed and graded according to CTCAEv5.0
Time frame: 12 weeks
Adverse Events
The emergence of new or worsening baseline symptoms, physical findings, or laboratory/imaging abnormalities. Causality to study treatment, immune checkpoint inhibitors, or underlying disease status will be investigator assessed and graded according to CTCAEv5.0.
Time frame: 12 weeks
Re-initiation of Immune Checkpoint Inhibitor Therapy
The proportion of participants in each study arm that are re-treated with an immune checkpoint inhibitor.
Time frame: 12 weeks
Progression Free Survival
The time elapsed between recruitment and tumor progression (radiographically or clinically) or death from any cause.
Time frame: Time Frame: Total study observation period (3 years)
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