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

• Status: Completed
• Trial end date: 2018-12-13
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the efficacy (activity), and tolerability of curcumin and cholecalciferol combination in treating patients with previously untreated stage 0-II chronic lymphocytic leukemia or small lymphocytic lymphoma. Curcumin and cholecalciferol may prevent or slow the growth of cancer cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paolo Caimi, MD
• Treatments: Cholecalciferol; Curcumin; Vitamin D

Criteria

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