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| ID | Type | Description | Link |
|---|---|---|---|
| GYN0007 | Other Identifier | OnCore | |
| NCI-2021-03444 | Registry Identifier | NCI- Clinical Trials Reporting Program |
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Lack of funding
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCSF | Drug | Granulocyte Colony Stimulating Factor (GCSF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Kidd, MD | Stanford Universiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute Palo Alto | Stanford | California | 94034 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 2 days. FDG PET/CT: Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT) GCSF: Granulocyte Colony Stimulating Factor (GCSF) |
| FG001 | 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) |
| FG002 | 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) |
| FG003 | Phase II- 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Up to 1 day after completing GCSF |
|
Up to 8 weeks after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Kidd | Stanford University | (650) 723-6171 | ekidd@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2023 | Feb 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
| 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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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
GCSF: Granulocyte Colony Stimulating Factor (GCSF)
| OG002 | 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF) |
|
|
| 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. | Posted | Count of Participants | Participants | Up to 7 weeks after starting treatment |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 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. GCSF: Granulocyte Colony Stimulating Factor (GCSF) | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 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 GCSF: Granulocyte Colony Stimulating Factor (GCSF) | 0 | 1 | 0 | 1 | 1 | 1 |
| Vaginal Hemmorhage | Reproductive system and breast disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Pain - Shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stomach Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Urinary Tract infection | Infections and infestations | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | Systematic Assessment |
|
| Lymphocyte Count Decreased | Investigations | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |