Colchicine for the Treatment of Post-Treatment Inflammation in Patients with Recurrent or Metastatic Solid Tumors or Urothelial Cancer

Inclusion Criteria

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately
• Age >= 18 years at the time of consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 28 days prior to registration. ECOG 2 is allowed for patients on Cohort 1.
• COHORT 1: Histological or cytologically confirmed solid tumor
• COHORT 1: Metastatic disease or recurrent disease
• COHORT 1: Elevated peripheral blood C-reactive protein (CRP) level (> 5mg/L) documented on routine bloodwork within 14 days prior to registration.
• COHORT 1: Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or evaluable disease (i.e. bone only metastatic disease or elevated tumor markers)
• COHORT 2: History of urothelial cancer post radical cystectomy, nephroureterectomy, or ureterectomy
• COHORT 2: Eligible and planned for standard of care adjuvant nivolumab in the opinion of the treating investigator
• COHORT 2: Elevated peripheral blood CRP level (>5 mg/L) documented on routine bloodwork at a minimum of 30 days and a maximum of 120 days after surgical resection and within 14 days prior to registration.
• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides. If archival tissue is not available, enrollment will be considered on a case by case basis after discussion with the principal investigator
• White blood cell (WBC) >= 2.5 K/mm^3 (within 14 days of registration)
• Absolute neutrophil count (ANC) >= 1.5 K/mm^3 (within 14 days of registration)
• Hemoglobin (Hgb) >= 8 g/dL (within 14 days of registration)
• Calculated glomerular filtration rate (GFR) >= 50 cc/min or creatinine =< 1.5 mg/dl (within 14 days of registration)
• Bilirubin =<1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin < 3.0 mg/dL) (within 14 days of registration)
• Aspartate aminotransferase (AST) =< 2.5 x ULN or <5 x ULN for patients in Cohort 1 with liver metastases (within 14 days of registration)
• Alanine aminotransferase (ALT) =< 2.5 x ULN or <5 x ULN for patients in Cohort 1 with liver metastases (within 14 days of registration)
• Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration
• Females of childbearing potential must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from the time of informed consent, during the study until after the last dose of study drug(s). Males must be willing to abstain from heterosexual activity or to use an effective method(s) of contraception from initiation of treatment until after the last dose of study drug(s)
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
• Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial
• As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion Criteria

• Already taking long term colchicine for any other reason
• Active infection requiring systemic therapy
• Pregnant or breastfeeding
• Prior cancer treatment must be completed at least 30 days prior to registration, or within 5 half-lives, and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to grade =< 1 or baseline
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per treating physician discretion, are not eligible for this trial
• Active central nervous system (CNS) metastases * NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) within 28 days prior to registration to exclude brain metastases * NOTE: A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off corticosteroids for >= 2 weeks, and are asymptomatic
• Treatment with any investigational drug within 30 days prior to registration
• Need for concomitant treatment with the medications
• Rheumatoid arthritis, vasculitis, systemic lupus erythematosus, or other autoimmune condition requiring active systemic treatment
• Myocardial infarction within the prior last 6 months and/or >= class III New York Heart Association heart failure
• Taking more than >10 mg prednisone daily or its equivalent dosage of corticosteroids within 28 days prior to study registration.