Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Adverse Events (AEs) and Significant Adverse Events (SAEs)
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A signed IRB - approved Informed Consent;
- •Women 18 - 80 years of age;
- •Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.
- •Whole breast radiation with or without ipsilateral axilla radiation therapy recommended by her radiation oncologist.
- •If a woman is of child-bearing potential, she and her partner must use an effective form of birth control.
- •Willing to participate in the clinical study and comply with the requirements of the trial.
排除标准
- •Abnormal liver or kidney function studies being greater than 2x the upper limit of normal.
- •Patients on hemodialysis
- •Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
- •History of non-compliance with treatment or clinical visit attendance.
- •Participation in an investigational trial within 30 days of study entry.
- •Women who are pregnant or lactating
研究组 & 干预措施
ST266 intact
Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The first cohort will receive ST266 and saline placebo applied to intact skin beginning immediately following the first radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.
干预措施: ST266 (Biological)
ST266 inflamed
Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The second cohort will receive ST266 and saline placebo applied to inflamed skin (after inflammation is first noted) beginning immediately following the radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.
干预措施: ST266 (Biological)
结局指标
主要结局
Adverse Events (AEs) and Significant Adverse Events (SAEs)
时间窗: Start of therapy through six week follow-up visit
次要结局
- Skin inflammation(start of therapy through six week follow-up visit)
- Quality of Life (QOL)scaled responses(start of therapy through one year follow-up)