Back to resultsBone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging
Primary Purpose
Cervix Cancer, Endometrial Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FDG PET/CT
GCSF
Sponsored by
About this trial
This is an interventional treatment trial for Cervix Cancer
Eligibility Criteria
Inclusion Criteria:
- 2018 international Federation of Gynecology and Obstetrics (FIGO) stage I IIIC1 cervix cancer with no prior treatment or stage IIIA IIIC1 endometrial cancer status post hysterectomy and lymph node assessment
- No required para aortic or extended field radiation
- Eastern Cooperative Oncology Group (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 109/L, platelets >100 x 109/L)
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Treatment for other cancer in the past 2 years
- Previous pelvic radiation
- Medical condition that prevents receiving chemotherapy
Sites / Locations
- Stanford Cancer Institute Palo AltoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Phase I -Dose finding, Cohort 1
Phase I -Dose finding, Cohort 2
Phase I -Dose finding, Cohort 3
Phase II-G-CSF
Arm Description
Dosing will occur in cohorts of 4 patients with the start at dose of GCSF will be 780 mcg x 3 days
Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 2 days
Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 1 day
Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study.
Outcomes
Primary Outcome Measures
Determine the Recommended phase 2 dose (RP2D)
Recommended phase 2 dose (RP2D) will be defined as the dose at which the standard uptake value (SUV) on D5 FDG PET reaches target SUVmean of 2.5 or higher with normalization of white blood cells (WBC) and ANC prior to start of radiation.
Determine the rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy)
Rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy) will be monitored by the regular CBC with differential on the study schema and calendar, as per standard of care for patients receiving chemoradiation and/or chemotherapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04514692
Brief Title
Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging
Official Title
Phase 1 2 Study of Individualized Bone Marrow Sparing Image Guided Radiotherapy Incorporating Novel Use of Granulocyte Colony Stimulating Factor and FDG PET Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This is a phase 1 and 2 study. The phase I 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 followup.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer, Endometrial Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase I -Dose finding, Cohort 1
Arm Type
Experimental
Arm Description
Dosing will occur in cohorts of 4 patients with the start at dose of GCSF will be 780 mcg x 3 days
Arm Title
Phase I -Dose finding, Cohort 2
Arm Type
Experimental
Arm Description
Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 2 days
Arm Title
Phase I -Dose finding, Cohort 3
Arm Type
Experimental
Arm Description
Dosing will occur in cohorts of 4 patients, If 4 out of 4 patients achieve the target SUVmean, the GCSF dose will be 780 mcg x 1 day
Arm Title
Phase II-G-CSF
Arm Type
Experimental
Arm Description
Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study.
Intervention Type
Diagnostic Test
Intervention Name(s)
FDG PET/CT
Intervention Description
Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)
Intervention Type
Drug
Intervention Name(s)
GCSF
Other Intervention Name(s)
Filgrastim, Neupogen, Zarxio, G-CSF
Intervention Description
Granulocyte Colony Stimulating Factor (GCSF)
Primary Outcome Measure Information:
Title
Determine the Recommended phase 2 dose (RP2D)
Description
Recommended phase 2 dose (RP2D) will be defined as the dose at which the standard uptake value (SUV) on D5 FDG PET reaches target SUVmean of 2.5 or higher with normalization of white blood cells (WBC) and ANC prior to start of radiation.
Time Frame
12 months
Title
Determine the rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy)
Description
Rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy) will be monitored by the regular CBC with differential on the study schema and calendar, as per standard of care for patients receiving chemoradiation and/or chemotherapy.
Time Frame
33 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
2018 international Federation of Gynecology and Obstetrics (FIGO) stage I IIIC1 cervix cancer with no prior treatment or stage IIIA IIIC1 endometrial cancer status post hysterectomy and lymph node assessment
No required para aortic or extended field radiation
Eastern Cooperative Oncology Group (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 109/L, platelets >100 x 109/L)
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Treatment for other cancer in the past 2 years
Previous pelvic radiation
Medical condition that prevents receiving chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camellia Djebroun
Phone
650-721-4076
Email
cdjebrou@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Kidd
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Institute Palo Alto
City
Stanford
State/Province
California
ZIP/Postal Code
94034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camellia Djebroun
Phone
650-721-4076
Email
cdjebrou@stanford.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth A Kidd
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging
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