Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging
- Conditions
- Cervix CancerEndometrial Cancer
- Interventions
- Drug: GCSF
- Registration Number
- NCT04514692
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 7
- 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.
- Treatment for other cancer in the past 2 years
- Previous pelvic radiation
- Medical condition that prevents receiving chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase I -Dose finding, Cohort 1 GCSF Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days Phase I -Dose finding, Cohort 2 GCSF 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 Phase I -Dose finding, Cohort 3 GCSF 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 Phase II-G-CSF GCSF Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³) 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford Cancer Institute Palo Alto
🇺🇸Stanford, California, United States