Phase 1-2 Study of Individualized Bone Marrow Sparing Image Guided Radiotherapy Incorporating Novel Use of Granulocyte Colony Stimulating Factor and FDG PET Imaging
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³)
研究概览
简要总结
This is a research study using Granulocyte Colony Stimulating Factor (GCSF) as a bone marrow stimulating agent for imaging to guide radiation treatment planning. G-CSF is a type of growth factor. Growth factors are proteins made in the body. G-CSF is a type of growth factor that makes the bone marrow produce white blood cells to reduce the risk of infection after some types of cancer treatment. GCSF is being given to stimulate the bone marrow to identify the active (blood cell producing regions) to better spare during pelvic radiation treatment planning.
详细描述
This is a phase 1/2 study. The phase 1 is a dose finding portion of the study and phase 2 will enroll additional patients at the dose found in phase I. Patients in phase I and phase 2 will have the same treatment and follow-up.
Participants will undergo standard of care diagnostic imaging, complete blood count (CBC) with differential and chemistry labs initially. While receiving the GCSF, participants will have a CBC with differential checked a day after each dose and one day prior to first day of radiation. The treatment planning FDG PET/CT will be performed shortly after the GCSF. During chemoradiation, participants will have weekly CBC with differential checked and other labs as standard of care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gynecologic cancer patients receiving pelvic radiation and chemotherapy, specifically: 1) Stage I-IIIC1 cervix cancer, 2) stage I-III primary vaginal cancer, 3) stage IIIA-IIIC1 endometrial cancer patients status post hysterectomy and lymph node assessment, and 4) recurrent endometrial cancer patients with pelvic confined disease No required para-aortic or extended field radiation
- •Age > 18 years
- •ECOG performance status 0-2
- •Adequate kidney function (serum Cr <1.5 or creatinine clearance >50 mg/dl)
- •Adequate bone marrow function (white blood cells > 3.0 X 10^9/L, platelets >100 x 10^9/L)
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Treatment for other cancer in the past 2 years
- •Previous pelvic radiation
- •Medical condition that prevents receiving chemotherapy
研究组 & 干预措施
Phase I -Dose finding, Cohort 1
Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days
干预措施: GCSF (Drug)
Phase I -Dose finding, Cohort 2
Dosing will occur in cohorts of 3 patients, If 3 out of 3 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 2 days
干预措施: GCSF (Drug)
Phase I -Dose finding, Cohort 3
Dosing will occur in cohorts of 3 patients, If 3 out of 3 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 1 day
干预措施: GCSF (Drug)
Phase II-G-CSF
Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study.
干预措施: GCSF (Drug)
结局指标
主要结局
Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³)
时间窗: Up to 7 weeks after starting treatment
Rate of grade 3 or greater neutropenia (ANC \< 1000/mm³ at any point of therapy) was monitored using regular complete blood count (CBC) with differential.
Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria
时间窗: Up to 1 day after completing GCSF
RP2D will be defined as the dose at which the standard uptake value (SUV) on D5 FDG PET reaches a target SUVmean of 2.5 or higher, with normalization of white blood cells (WBC) and absolute neutrophil count (ANC) prior to the start of radiation. The outcome will be reported as the number of participants who meet these criteria.
次要结局
未报告次要终点
研究者
Elizabeth Kidd
Associate Professor of Radiation Oncology (Radiation Therapy)
Stanford University