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

NCT02100423 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CASE5913
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)

  The point estimate of the overall response rate (biologic response rate + complete response \[CR\] + partial response \[PR\]) with 95% confidence intervals will be calculated using binomial distribution theory. The time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented and assessed

  Up to 2 years

Secondary Outcomes (4)

• Time to First Cytotoxic Treatment (TFCT)

  Up to 2 years

• Percent of Participants With Progression Free Survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

• Duration of Response

  Up to 2 years

Study Arms (1)

Treatment (curcumin, cholecalciferol)

EXPERIMENTAL

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.

Drug: curcumin; Dietary Supplement: cholecalciferol; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

curcumin DRUG

Given PO

Also known as: C.I. 75300, C.I. Natural Yellow 3, CU, Diferuloylmethane

Treatment (curcumin, cholecalciferol)

cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: Calciol, Vitamin D3

Treatment (curcumin, cholecalciferol)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (curcumin, cholecalciferol)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (curcumin, cholecalciferol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paolo Caimi, MD: lead

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Curcumin; Cholecalciferol

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Paolo Caimi
• Organization: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

paolo.caimi@uhhospitals.org

1-800-641-2422

Study Officials

• Paolo Caimi

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: October 16, 2014
• Primary Completion: April 4, 2018
• Study Completion: December 13, 2018
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2024-03

Locations

US (1)