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

NCT ID: NCT02100423

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-16
• Study Completion Date: 2018-12-13

Brief 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.

Detailed Description

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.

Conditions

Contiguous Stage II Small Lymphocytic Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Stage 0 Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage I Small Lymphocytic Lymphoma; Stage II Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (curcumin, cholecalciferol)

Patients receive curcumin 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.

Group Type: EXPERIMENTAL

curcumin

Intervention Type: DRUG

Given PO

cholecalciferol

Intervention Type: DIETARY_SUPPLEMENT

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

curcumin

Given PO

Intervention Type: DRUG

cholecalciferol

Given PO

Intervention Type: DIETARY_SUPPLEMENT

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

C.I. 75300; C.I. Natural Yellow 3; CU; Diferuloylmethane; Calciol; Vitamin D3; pharmacological studies

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paolo Caimi, MD

OTHER

Sponsor Role: lead

Responsible Party

Paolo Caimi, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paolo Caimi

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CASE5913

Identifier Type: -

Identifier Source: org_study_id