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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02100423
First received: March 27, 2014
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
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
Dietary Supplement: curcumin
Dietary Supplement: cholecalciferol
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The point estimate of the overall response rate and biologic response rate along with 95% confidence intervals will be calculated using binomial distribution theory.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.

  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Kaplan-Meier method and Cox proportional hazard model will be used for the data analysis.

  • Duration of response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: September 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02100423

Locations
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Basem M. William    216-983-4753    basem.william@uhhospitals.org   
Principal Investigator: Basem M. William         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Basem William Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02100423     History of Changes
Other Study ID Numbers: CASE5913, NCI-2014-00266, CASE5913, P30CA043703
Study First Received: March 27, 2014
Last Updated: October 3, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Leukemia, Lymphoid
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cholecalciferol
Curcumin
Vitamin D
Vitamins
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Bone Density Conservation Agents
Central Nervous System Agents
Enzyme Inhibitors
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014