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

NCT04514692 | Terminated Phase 1 Results DMC FDA Drug

• 3 other identifiers: IRB-56842GYN0007NCI-2021-03444
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix Cancer; Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria

  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.

  Up to 1 day after completing GCSF

• Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³)

  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.

  Up to 7 weeks after starting treatment

Study Arms (4)

Phase I -Dose finding, Cohort 1

EXPERIMENTAL

Dosing will occur in cohorts of 3 patients with the start at dose of GCSF will be 780 mcg x 3 days

Drug: GCSF

Phase I -Dose finding, Cohort 2

EXPERIMENTAL

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

Drug: GCSF

Phase I -Dose finding, Cohort 3

EXPERIMENTAL

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

Drug: GCSF

Phase II-G-CSF

EXPERIMENTAL

Phase 2 participants will be treated with the optimal dose of GCSF found in the phase 1 portion of the study.

Drug: GCSF

Interventions

GCSF DRUG

Granulocyte Colony Stimulating Factor (GCSF)

Also known as: Filgrastim, Neupogen, Zarxio, G-CSF

Phase I -Dose finding, Cohort 1; Phase I -Dose finding, Cohort 2; Phase I -Dose finding, Cohort 3; Phase II-G-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Institute Palo Alto

Stanford, California, 94034, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Elizabeth Kidd
• Organization: Stanford University

ekidd@stanford.edu

(650) 723-6171

Study Officials

• Elizabeth A Kidd, MD

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology (Radiation Therapy)

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: February 1, 2021
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)