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

PRIMARY OBJECTIVES:

I. To determine the overall response rate (ORR) based on National Cancer Institute-Working
Group (NCI-WG) criteria in chronic lymphocytic leukemia (CLL) or the Cheson criteria in small
lymphocytic lymphoma (SLL).

SECONDARY OBJECTIVES:

I. To determine the time to first cytotoxic treatment (TFCT), progression free survival
(PFS), and overall survival (OS) using this regimen.

OUTLINE:

Patients receive curcumin orally (PO) daily on days 1-28 and cholecalciferol PO daily on days
8-28 of course 1 and days 1-28 of subsequent courses. Treatment repeats every 28 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity. Patients
achieving partial response or better may receive treatment for a total of 2 years.

After completion of study treatment, patients are followed up for 30 days and then every 3-6
months for 2 years.

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