Clinical trial

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

Name

IRB-56842

Description

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.

Trial arms

Trial start

2021-02-01

Estimated PCD

2025-05-01

Trial end

2026-05-01

Status

Recruiting

Phase

Early phase I

Treatment

FDG PET/CT

Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)

Arms:

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

GCSF

Granulocyte Colony Stimulating Factor (GCSF)

Arms:

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

Other names:

Filgrastim, Neupogen, Zarxio, G-CSF

Size

Primary endpoint

Determine the Recommended phase 2 dose (RP2D)

12 months

Determine the rate of grade 3 or greater neutropenia (ANC < 1000/mm3 at any point of therapy)

33 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 29, 'type': 'ESTIMATED'}}

Updated at

2023-03-10

1 organization

1 drug

2 indications

Organization

Drug

Indication

Indication