Overview

This trial is active, not recruiting.

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
Treatments curcumin, cholecalciferol, laboratory biomarker analysis, pharmacological study
Phase phase 2
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date September 2014
End date May 2016
Trial size 35 participants
Trial identifier NCT02100423, CASE5913, NCI-2014-00266, P30CA043703

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
curcumin C.I. 75300
Given PO
cholecalciferol Calciol
Given PO
laboratory biomarker analysis
Correlative studies
pharmacological study pharmacological studies
Correlative studies

Primary Outcomes

Measure
Overall response rate (biologic response rate + complete response [CR] + partial response [PR]) based on NCI-WG (for CLL) and Cheson criteria (for SLL)
time frame: The time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years

Secondary Outcomes

Measure
Time to first cytotoxic treatment
time frame: Time from entry onto study until initiation of treatment with cytotoxic agents because of disease progression, assessed up to 2 years
Progression free survival
time frame: Time from entry onto study until CLL/SLL progression or death from any cause, assessed up to 2 years
Overall survival
time frame: Up to 2 years
Duration of response
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Study of Curcumin and Vitamin D in Previously Untreated Patients With Early Stage Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Principal investigator Paolo Caimi
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.