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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02100423
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paolo Caimi, MD, Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE March 27, 2014
First Posted Date  ICMJE April 1, 2014
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE September 26, 2014
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
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 ]
The point estimate of the overall response rate and biologic response rate along with 95% confidence intervals will be calculated using binomial distribution theory.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • 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 ]
    Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
  • Progression free survival [ Time Frame: Time from entry onto study until CLL/SLL progression or death from any cause, assessed up to 2 years ]
    Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
  • Overall survival [ Time Frame: Up to 2 years ]
    Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.
  • Duration of response [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: curcumin
    Given PO
    Other Names:
    • C.I. 75300
    • C.I. Natural Yellow 3
    • CU
    • Diferuloylmethane
  • Dietary Supplement: cholecalciferol
    Given PO
    Other Names:
    • Calciol
    • Vitamin D3
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Drug: curcumin
  • Dietary Supplement: cholecalciferol
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2014)
35
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 13, 2018
Actual Primary Completion Date April 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02100423
Other Study ID Numbers  ICMJE CASE5913
NCI-2014-00266 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE5913 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paolo Caimi, MD, Case Comprehensive Cancer Center
Study Sponsor  ICMJE Paolo Caimi, MD
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Paolo Caimi Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP