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

Stanford University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Endometrial Cancer; Cervix Cancer

Treatments: Drug: GCSF

Study type: Interventional

Funder types: Other

Identifiers

NCT04514692

GYN0007 (Other Identifier)

NCI-2021-03444 (Registry Identifier)

IRB-56842

Details and patient eligibility

About

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.

Full description

This is a phase 1/2 study. The phase 1 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 follow-up.

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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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7 participants in 4 patient groups

Phase I -Dose finding, Cohort 1

Experimental group

Description:

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

Treatment:

Drug: GCSF

Phase I -Dose finding, Cohort 2

Experimental group

Description:

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

Treatment:

Drug: GCSF

Phase I -Dose finding, Cohort 3

Experimental group

Description:

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

Treatment:

Drug: GCSF

Phase II-G-CSF

Experimental group

Description:

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

Treatment:

Drug: GCSF