Actively Recruiting
Immune-Mediated Pathophysiology And Clinical Triage Program
Led by AHS Cancer Control Alberta · Updated on 2025-06-18
46
Participants Needed
1
Research Sites
406 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 a number of side effects, and it is not known if this is the best or safest treatment. Hydroxychloroquine is a medication that is often used to treat inflammatory joint pain, such as rheumatoid arthritis, has relatively few side effects when compared to prednisone, and may be effective at treating this condition. The purpose of this study is to find out whether it is better to receive hydroxychloroquine and prednisone, or prednisone alone for joint pain. To do this, some participants will get hydroxychloroquine and some will receive a placebo (a substance that looks like the study drug but does not have any active or medicinal ingredients). A placebo is used to make the results of the study more reliable. This is a double-blinded study, which means that neither participants nor the study doctor or study staff will know which group participants are allocated. After 12 weeks of study treatment, the blind will be opened and participants will be informed which treatment was given.
CONDITIONS
Official Title
Immune-Mediated Pathophysiology And Clinical Triage Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older
- Patients must be able to provide consent for enrollment and treatment
- Patients must have a performance status of ECOG 0-2
- Patients with confirmed cancer receiving anti-PD1 or anti-PDL1 therapy, alone or with anti-CTLA4 therapy, who develop grade 62 arthritis or arthralgia related to immune checkpoint inhibitor therapy
- Adequate liver function with AST, ALT, and alkaline phosphatase 6 2.5 times the upper limit of normal
- Total bilirubin 6 1.5 times the upper limit of normal
- Kidney function with serum creatinine within normal limits or creatinine clearance 6 60 mL/min
- Women of childbearing potential must have a negative pregnancy test at screening
- Patients of reproductive potential must use highly effective birth control during and for 3 months after treatment
- Breast-feeding females must stop nursing before treatment and for 3 months after last dose
- Male patients must agree not to donate sperm during treatment and for 3 months after last dose
- No conditions that would prevent compliance with the study protocol and follow-up
You will not qualify if you...
- History of inflammatory arthritis such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, or ankylosing spondylitis
- Need for systemic immunosuppressive medications or corticosteroids
- Patients with grade 62 immune-related adverse events other than arthritis or arthralgia, except certain endocrinopathies treated only with hormone replacement
- Weight less than 40 kg
- G6PD deficiency, porphyria, or psoriasis
- Active significant cardiovascular disease including recent stroke, heart attack, unstable angina, heart failure above Class II, or serious arrhythmia
- Prolonged QT interval or use of medications that prolong QT interval
- Diagnosis of immunodeficiency
- Current use of immunosuppressive medications except certain topical or inhaled steroids
- Known severe allergy to study drug or components, including severe reactions to monoclonal antibodies
- Severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study participation, including recent or active suicidal ideation or behavior, and abnormal labs that may increase risk or affect study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
Research Team
M
Michael Kolinsky
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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