Cervix Cancer, Endometrial Cancer
Conditions
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.
Detailed 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.
Interventions
DRUGGCSF
Granulocyte Colony Stimulating Factor (GCSF)
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria | Up to 1 day after completing GCSF | 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. |
| Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 3 days
FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)
GCSF: Granulocyte Colony Stimulating Factor (GCSF) | 3 |
| 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) | 3 |
| 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) | 1 |
| Total | 7 |
Baseline characteristics
| Characteristic | Phase I -Dose Finding, Cohort 1 | Phase I -Dose Finding, Cohort 2 | Phase I -Dose Finding, Cohort 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 1 participants | 7 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 1 / 1 |
| serious Total, serious adverse events | 1 / 3 | 1 / 3 | 0 / 1 |
Outcome results
Primary
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.
Time frame: Up to 1 day after completing GCSF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I -Dose Finding, Cohort 1 | Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria | 3 Participants |
| Phase I -Dose Finding, Cohort 2 | Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria | 3 Participants |
| Phase I -Dose Finding, Cohort 3 | Number of Participants Achieving Recommended Phase 2 Dose (RP2D) Criteria | 0 Participants |
Primary
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.
Time frame: Up to 7 weeks after starting treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase I -Dose Finding, Cohort 1 | Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³) | 0 Participants |
| Phase I -Dose Finding, Cohort 2 | Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³) | 1 Participants |
| Phase I -Dose Finding, Cohort 3 | Number of Participants Experiencing Grade 3 or Greater Neutropenia (ANC < 1000/mm³) | 0 Participants |