Clinical trial NCT02100423: Curcumin and Cholecalciferol in Treating Patients With Previously Untreated Stage 0-II Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-04-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Time to First Cytotoxic Treatment (TFCT)
timeFrame: Up to 2 years
measure: Percent of Participants With Progression Free Survival (PFS)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Duration of Response
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Paolo Caimi
role: PRINCIPAL_INVESTIGATOR
References: