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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: curcumin (Drug)
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.
干预措施: cholecalciferol (Dietary Supplement)
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.
干预措施: laboratory biomarker analysis (Other)
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.
干预措施: pharmacological study (Other)
结局指标
主要结局
Overall Response Rate Based on NCI-WG (for CLL) and Cheson Criteria (for SLL)
时间窗: Up to 2 years
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
次要结局
- Percent of Participants With Progression Free Survival (PFS)(Up to 2 years)
- Duration of Response(Up to 2 years)
- Time to First Cytotoxic Treatment (TFCT)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
研究者
Paolo Caimi, MD
Principal Investigator
Case Comprehensive Cancer Center