Trial Outcomes & Findings for Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging (NCT NCT04514692)

Last Updated: 2025-04-23

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 1 day after completing GCSF

Results posted on

2025-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	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 2 days. FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) GCSF: Granulocyte Colony Stimulating Factor (GCSF)	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. FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) GCSF: Granulocyte Colony Stimulating Factor (GCSF)	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 FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) GCSF: Granulocyte Colony Stimulating Factor (GCSF)
Overall Study STARTED	3	3	1
Overall Study COMPLETED	3	3	1
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I -Dose Finding, Cohort 1 n=3 Participants Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 2 n=3 Participants 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 FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 3 n=1 Participants 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 FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	7 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 1 day after completing GCSF

Outcome measures

Outcome measures
Measure	Phase I -Dose Finding, Cohort 1 n=3 Participants Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 2 n=3 Participants 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 3 n=1 Participants 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF)
Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria	3 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase I -Dose Finding, Cohort 1 n=3 Participants Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 2 n=3 Participants 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 3 n=1 Participants 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF)
Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³)	0 Participants	1 Participants	0 Participants

Adverse Events

Phase I -Dose Finding, Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase I -Dose Finding, Cohort 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase I -Dose Finding, Cohort 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I -Dose Finding, Cohort 1 n=3 participants at risk Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 2 n=3 participants at risk 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. GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 3 n=1 participants at risk 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF)
Hepatobiliary disorders Cholecystitis	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/3 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Reproductive system and breast disorders Vaginal Hemmorhage	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.

Other adverse events

Other adverse events
Measure	Phase I -Dose Finding, Cohort 1 n=3 participants at risk Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 2 n=3 participants at risk 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. GCSF: Granulocyte Colony Stimulating Factor (GCSF)	Phase I -Dose Finding, Cohort 3 n=1 participants at risk 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF)
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 3 • Up to 8 weeks after treatment.	66.7% 2/3 • Number of events 3 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 1 • Up to 8 weeks after treatment.
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
General disorders Fatigue	100.0% 3/3 • Number of events 3 • Up to 8 weeks after treatment.	66.7% 2/3 • Number of events 2 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/3 • Up to 8 weeks after treatment.	66.7% 2/3 • Number of events 2 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 8 weeks after treatment.	66.7% 2/3 • Number of events 2 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 2 • Up to 8 weeks after treatment.
Musculoskeletal and connective tissue disorders Pain - Shoulder	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Gastrointestinal disorders Stomach Pain	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Gastrointestinal disorders Bloating	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Infections and infestations Urinary Tract infection	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Up to 8 weeks after treatment.	0.00% 0/3 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 1 • Up to 8 weeks after treatment.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/3 • Up to 8 weeks after treatment.	0.00% 0/3 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 1 • Up to 8 weeks after treatment.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/3 • Up to 8 weeks after treatment.	0.00% 0/3 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 1 • Up to 8 weeks after treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • Up to 8 weeks after treatment.	0.00% 0/3 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 1 • Up to 8 weeks after treatment.
Investigations White Blood Cell Count Decreased	100.0% 3/3 • Number of events 7 • Up to 8 weeks after treatment.	100.0% 3/3 • Number of events 7 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 2 • Up to 8 weeks after treatment.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 6 • Up to 8 weeks after treatment.	66.7% 2/3 • Number of events 7 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 1 • Up to 8 weeks after treatment.
Investigations Platelet Count Decreased	0.00% 0/3 • Up to 8 weeks after treatment.	66.7% 2/3 • Number of events 2 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Investigations Neutrophil Count Decreased	33.3% 1/3 • Number of events 2 • Up to 8 weeks after treatment.	66.7% 2/3 • Number of events 5 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Investigations Lymphocyte Count Decreased	100.0% 3/3 • Number of events 5 • Up to 8 weeks after treatment.	100.0% 3/3 • Number of events 7 • Up to 8 weeks after treatment.	100.0% 1/1 • Number of events 2 • Up to 8 weeks after treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 2 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 2 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Investigations Alkaline phosphatase increased	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 1 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Up to 8 weeks after treatment.	33.3% 1/3 • Number of events 2 • Up to 8 weeks after treatment.	0.00% 0/1 • Up to 8 weeks after treatment.

Additional Information

Dr. Elizabeth Kidd

Stanford University

Phone: (650) 723-6171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place