An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Maximum curcumin tolerated dose
研究概览
简要总结
The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions (aHSIL) (high-grade anal precancerous cells or high-grade abnormal cells) in people living with HIV to avoid current treatments such as ablation (destroying abnormal cells with heat or surgical excision (cutting out the abnormal cells)), which have potential short- and long-term side effects.
详细描述
This proposal suggests conducting a Phase I clinical trial using a 3 + 3 dose escalation approach to assess the safety and determine the maximum tolerated dose of intra-anal curcumin in individuals with HIV who have anal high-grade squamous intraepithelial lesions (aHSIL/AIN 2-3). Currently, there is a significant need for non-surgical treatments for pre-malignant anal diseases in people with HIV, aiming to reduce risks and complications associated with existing surgical and topical interventions.
Curcumin, a compound derived from turmeric, is known for its anti-inflammatory and anti-infectious properties. While previous research has shown its anticancer effects in oral doses, its bioavailability is limited, and intra-anal administration has not been studied in humans. This trial aims to explore the potential of intra-anal curcumin as an alternative treatment for aHSIL in people with HIV.
The study will involve enrolling participants with aHSIL and administering increasing doses of curcumin intra-anally for 14 days, following the 3 + 3 dose escalation model. The trial will continue until the dose-limiting toxicity (DLT) level is reached, and participants report symptoms necessitating a dose reduction.
To enhance future studies, the researchers will also evaluate patient and male partner acceptability through questionnaires. The insights gained from this trial will guide the design of subsequent efficacy and safety studies for individuals with AIN 2 and 3 neoplasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Major Inclusion Criteria:
- •30 and older
- •Have biopsy-proven anal intraepithelial neoplasia (AIN) 2, AIN 3 without previous treatment
- •Or cytology results for ASC-H or HSIL
- •Able and willing to complete Study Diary
- •Other inclusion criteria apply
排除标准
- •Have a clinically significant chronic medical condition that is considered progressive, such as but not limited to coronary disease, congestive heart failure, chronic obstructive lung disease, and diabetes mellitus. Chronic nonprogressive or intermittent syndromes are not excluded, including migraine headaches, mild reactive airway disease, controlled hypertension, stable pain syndromes, or benign gastric reflux.
- •Have any history of anal cancer malignancy.
- •Pregnant or planning to become pregnant in the next three months.
- •Have a history of sensitivity or allergy to any compound used in this study.
- •Have Grade 2 or higher renal or hematology abnormality,
- •Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), recreational drugs, or alcohol abuse.
- •Other exclusion criteria apply
研究组 & 干预措施
Dose Level 1
Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
Dose Level 2
Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
Dose Level 3
Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
Dose Level 4
Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
Dose Level 5
Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
Dose Level 6
Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
Dose Level 7
Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
Dose Level 8
Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period
干预措施: Curcuminoid Capsules (Drug)
结局指标
主要结局
Maximum curcumin tolerated dose
时间窗: Up to 22 days after treatment
To determine the maximum tolerated dose (MTD) of curcumin, toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced. The dose level at which no more than 33% of study participants have a DLT will be considered the maximum tolerated dose.
次要结局
- Anoscopy changes(22 days after treatment)
- Toxicity related to treatment(Up to 22 days after treatment)
研究者
Lisa Flowers
Professor
Emory University