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

Phase 1

Recruiting

• Conditions: Cervix Cancer; Endometrial Cancer
• Interventions: Diagnostic Test: FDG PET/CT; 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.

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 Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-17
• Study Start: 2021-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 29

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.

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Exclusion Criteria

• Treatment for other cancer in the past 2 years
• Previous pelvic radiation
• Medical condition that prevents receiving chemotherapy

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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 4 patients with the start at dose of GCSF will be 780 mcg x 3 days
Phase I -Dose finding, Cohort 1	FDG PET/CT	Dosing will occur in cohorts of 4 patients with the start at dose of GCSF will be 780 mcg x 3 days
Phase I -Dose finding, Cohort 3	FDG PET/CT	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 I -Dose finding, Cohort 3	GCSF	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 I -Dose finding, Cohort 2	FDG PET/CT	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
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.
Phase I -Dose finding, Cohort 2	GCSF	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
Phase II-G-CSF	FDG PET/CT	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
Determine the Recommended phase 2 dose (RP2D)	12 months	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)	33 months	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.

Trial Locations

Locations (1)

Stanford Cancer Institute Palo Alto; 🇺🇸 Stanford, California, United States