Radiation to Treat Joint Damage Caused by Cancer Immunotherapy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Chicago
About this trial
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
Eligibility criteria
Qualifiers
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which they are receiving single agent or combination immunotherapy or within the last 6 months.
Rheumatologist-established diagnosis of new onset CTCAE grade 2-3 immunotherapy-induced inflammatory arthritis or activated osteoarthritis, involving one or more joints (up to 3) including but not limited to hands, shoulders, elbows, hips, knees and ankles.
Age ≥ 40 years.
ECOG performance status ≤2 (Karnofsky ≥60%).
Disqualifiers
Contraindications to radiation treatment, such as pregnancy, breast-feeding women and active collagen-vascular disease.
Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was >1 year prior to consent and/or clear documentation states that the patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment.
Have not received systemic steroids within the last 3 months for the treatment of immune related adverse events.
History of prior autoimmune conditions, or concurrent immune related adverse events requiring systemic immunosuppressants.
Trial design
Treatments tested in this trial
- Low dose radiation therapy
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov