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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05091866
Other study ID # STUDY00002155
Secondary ID NCI-2021-01498WI
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date April 11, 2022
Est. completion date August 25, 2026

Study information

Verified date June 2024
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This early phase I trial identifies the best dose, possible benefits and/or side effects of natural progesterone in treating patients with glioblastoma that has come back (recurrent). Progesterone is a type of hormone made by the body that plays a role in the menstrual cycle and pregnancy. Progesterone may help control tumor growth and spread in patients with glioblastoma.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Biological:
Therapeutic Progesterone
Given SC

Locations

Country Name City State
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Emory University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Progesterone receptor expression levels Original tumor and any recurrent tumor samples will be assessed for progesterone receptor expression levels by immunohistochemistry and these results will be correlated with response assessment to determine whether there is any correlation. Up to 2 years
Other Tumor mutational and genomic loss/gain factors Each of the tumor mutational and genomic loss/gain factors will be scored and these results will be correlated with response assessment to determine whether there is any correlation. Up to 2 years
Other EORTC Quality-of-life (QOL) Questionnaire Core 30/Brain Cancer Module-20 Serial QOL assessments will be determined in patients and compared with historical cohorts to determine whether there is any difference in patients treated with subcutaneous progesterone for recurrent GBM. Up to 2 years
Other YKL-40 biomarker analysis YKL-40 will be quantitated at the specific time points (pre-treatment, 4 weeks, 8 weeks) with specific levels and changes in levels recorded. These results will be correlated with response assessment to determine whether there is any correlation. Up to 8 weeks
Other Matrix Meteloproteinase-9 (MMP-9) Matrix Meteloproteinase-9 (MMP-9) will be quantitated at the specific time points (pre-treatment, 4 weeks, 8 weeks) with specific levels and changes in levels recorded. These results will be correlated with response assessment to determine whether there is any correlation. Up to 8 weeks
Other Gilal Fibrillary Acidic Protein Gilal Fibrillary Acidic Protein will be quantitated at the specific time points (pre-treatment, 4 weeks, 8 weeks) with specific levels and changes in levels recorded. These results will be correlated with response assessment to determine whether there is any correlation. Up to 8 weeks
Other C-Reactive Protein C-Reactive Protein will be quantitated at the specific time points (pre-treatment, 4 weeks, 8 weeks) with specific levels and changes in levels recorded. These results will be correlated with response assessment to determine whether there is any correlation. Up to 8 weeks
Other Soluble CD14 Soluble CD14 will be quantitated at the specific time points (pre-treatment, 4 weeks, 8 weeks) with specific levels and changes in levels recorded. These results will be correlated with response assessment to determine whether there is any correlation. Up to 8 weeks
Other Soluble CD23 Soluble CD23 will be quantitated at the specific time points (pre-treatment, 4 weeks, 8 weeks) with specific levels and changes in levels recorded. These results will be correlated with response assessment to determine whether there is any correlation. Up to 8 weeks
Primary Natural progesterone blood levels This analysis will be performed to determine what plasma drug levels can be achieved in recurrent glioblastoma (GBM) patients with subcutaneous administration of natural progesterone and whether this is in line with what was previously determined in healthy subjects. On day 1 (0, 30 minutes, 1, 2, 4, 6, 8 hours from drug injection) as well as at day 4 and day 8 prior to drug injections
Primary Incidence of adverse events The safety of this approach will be confirmed by assessing toxicity potentially attributable to the daily progesterone treatment. Toxicity will be determined by Common Terminology Criteria for Adverse Events version 5.0 criteria. Up to 2 years
Primary Overall response rate Will be looking for the fraction of patients that are able to maintain at least stable disease. Up to 2 years
Secondary Progression free survival (PFS) Patients on this study will be followed for PFS. In addition to the 24 weeks PFS, actuarial PFS curves will be assessed and compared to historical controls. From the time of pre-treatment magnetic resonance imaging (MRI) to the time of either radiographic progression or death, whichever occurs first, assessed at 24 weeks
Secondary Overall survival (OS) Patients on this study will be followed for OS. In addition to the 24 weeks OS, actuarial OS curves will be assessed and compared to historical controls. From the time of pre-treatment MRI to the time of death, assessed at 24 weeks
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