Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This is an interventional treatment trial for Contiguous Stage II Small Lymphocytic Lymphoma Read More

Inclusion Criteria:

• Have a diagnosis of CLL based on peripheral blood flow cytometry and/or bone marrow aspiration and biopsy OR diagnosis of SLL based on lymph node or bone marrow biopsy; patients with SLL need to have measurable disease
• Performance status (Eastern Cooperative Oncology Group [ECOG]) 0-2
• Patients must have not received any prior treatment for CLL or SLL
• Patients must be stage 0-II based on Rai staging system; must have no indication for treatment for SLL per NCI-WG criteria
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 10 g/dL
• Serum creatinine =< 2.0 g/dL or calculated creatinine clearance (CrCl) >= 60mL/min (Cockcroft-Gault method)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (ULN)
• Bilirubin < 2.0 x ULN, unless subject has Gilbert's disease
• Calcium < 10.1 mg/dL (corrected to serum albumin)
• Females will be either postmenopausal for at least 1 year or surgically sterile for at least 3 months OR females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment
• Able to comprehend and willing to sign an Informed Consent Form (ICF)
• Subjects must be off any steroids 7 days prior to the initiation of treatment
• Subjects must be off any curcumin, tumeric, or vitamin D supplements for 14 days prior to the initiation of treatment
• Subjects must be able to take oral medications

Exclusion Criteria:

• Presence of malignancy (other than the one treated in this study) which required systemic treatment within the past 3 years
• Any indication to start treatment for CLL based on NCI-WG criteria
• Prior therapy for CLL/SLL
• Subjects who are pregnant or breast-feeding; breastfeeding should be discontinued if the mother is treated with curcumin

• Concurrent medical condition which may increase the risk of toxicity, including:

  • Hypercalcemia of any cause
  • Untreated hyperparathyroidism
  • Paget's disease of bone
• Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician; subjects receiving antibiotics that are under control may be included in the study
• Inability to take oral medications
• Patients receiving other investigational agent
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to curcumin or vitamin D or other agents used in this study
• Patients on therapeutic anticoagulation, with heparin (or low-molecular weight heparin), warfarin, or a direct thrombin inhibitor as the safety of concurrent administration of curcumin has not been established
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible