Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging

Phase 1 2 Study of Individualized Bone Marrow Sparing Image Guided Radiotherapy Incorporating Novel Use of Granulocyte Colony Stimulating Factor and FDG PET Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: Cervix Cancer; Endometrial Cancer
• Intervention / Treatment: Diagnostic test: FDG PET/CT; Drug: GCSF

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.

• Study Type: Interventional
• Enrollment (Anticipated): 29
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Camellia Djebroun; Phone Number: 650-721-4076; Email: cdjebrou@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94034
      • Recruiting
      • Stanford Cancer Institute Palo Alto
      • Contact: Camellia Djebroun; Phone Number: 650-721-4076; Email: cdjebrou@stanford.edu
      • Principal Investigator: Elizabeth A Kidd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase I -Dose finding, Cohort 1; Dosing will occur in cohorts of 4 patients with the start at dose of GCSF will be 780 mcg x 3 days	Diagnostic test: FDG PET/CT; Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT); Drug: GCSF; Granulocyte Colony Stimulating Factor (GCSF); Other Names: Filgrastim; G-CSF; Neupogen; Zarxio
Experimental: Phase I -Dose finding, Cohort 2; 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	Diagnostic test: FDG PET/CT; Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT); Drug: GCSF; Granulocyte Colony Stimulating Factor (GCSF); Other Names: Filgrastim; G-CSF; Neupogen; Zarxio
Experimental: Phase I -Dose finding, Cohort 3; 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	Diagnostic test: FDG PET/CT; Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT); Drug: GCSF; Granulocyte Colony Stimulating Factor (GCSF); Other Names: Filgrastim; G-CSF; Neupogen; Zarxio
Experimental: 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.	Diagnostic test: FDG PET/CT; Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT); Drug: GCSF; Granulocyte Colony Stimulating Factor (GCSF); Other Names: Filgrastim; G-CSF; Neupogen; Zarxio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	33 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Elizabeth A Kidd, Stanford Universiy

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: IRB-56842; GYN0007 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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