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

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04514692
Collaborator
(none)
29
Enrollment
1
Location
4
Arms
36
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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
  • Neupogen
  • Zarxio
  • G-CSF

    		•
    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
  • Neupogen
  • Zarxio
  • G-CSF

    		•
    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
  • Neupogen
  • Zarxio
  • G-CSF

    		•
    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
  • Neupogen
  • Zarxio
  • G-CSF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford Cancer Institute Palo Alto Stanford California United States 94034

    Sponsors and Collaborators

    • Stanford University

    Investigators

    • Principal Investigator: Elizabeth A Kidd, Stanford Universiy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stanford University
    ClinicalTrials.gov Identifier:
    NCT04514692
    Other Study ID Numbers:
    • IRB-56842
    • GYN0007
    First Posted:
    Aug 17, 2020
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Uterine Cervical Neoplasms
    Lenograstim

    Study Results

    No Results Posted as of Aug 19, 2022