An Early Phase 1 interventional study of Quality-of-Life Assessment and Questionnaire Administration in Gliosarcoma and Recurrent Glioblastoma, sponsored by Emory University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Emory University · Early Phase 1, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. To determine that the pharmacokinetics of natural progesterone given to recurrent glioblastoma [GBM] patients by subcutaneous injection is consistent with previous determinations made given subcutaneously using the aqueous formulation of progesterone.
II. To determine the safety of administering daily subcutaneous natural progesterone for the treatment of patients with recurrent GBMs.
III. To determine the rate of stable disease (SD) or better (partial response [PR] or complete response [CR]) at 8 weeks in eligible patients with recurrent GBM treated with daily subcutaneous natural progesterone.
SECONDARY OBJECTIVES:
I. To determine and compare the progression free survival of eligible patients with recurrent GBM compared with matched historical controls treated with a range of standard therapies.
II. To determine and compare the overall survival of eligible patients with recurrent GBM compared with matched historical controls treated with a range of standard therapies.
EXPLORATORY OBJECTIVES:
I. To determine whether progesterone receptor levels within the tumor correlates with response to daily subcutaneous natural progesterone.
II. To determine if other intrinsic tumor factors (mutations and genomic loss/gains) correlates with response to daily subcutaneous natural progesterone.
III. To determine if the absolute values or changes in the level of serum biomarkers correlates with response to daily subcutaneous natural progesterone.
IV. To determine the quality-of-life (QOL) by validated instruments of eligible patients with recurrent GBM treated with daily subcutaneous natural progesterone and assess whether this differs from historical controls.
OUTLINE:
Patients receive progesterone subcutaneously (SC) once daily (QD) for up to 24 weeks in the absence of disease progression or unacceptable toxicity.
488 studies on the registry are indexed under Gliosarcoma; 14 are open to participants now.
This study's enrollment of 4 is below the median of 37 across 389 interventional studies indexed under Gliosarcoma.
Browse Gliosarcoma studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive progesterone SC QD for up to 24 weeks in the absence of disease progression or unacceptable toxicity.
Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Biological: Therapeutic Progesterone
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Given SC
Also known as: Corlutina, Corluvite, Corpus luteum hormone, Cyclogest, Gestiron, Gestone, Lipo-Lutin, Luteohormone, Lutocyclin, Lutocylin M, Lutogyl, Lutromone, Progestasert, Progesterone, Progestin, Progestogel, Progestol, Progeston, Prolidon, Proluton, Syngesterone, Utrogestan
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.
Time frame: 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
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.
Time frame: Up to 2 years
Overall response rate
Will be looking for the fraction of patients that are able to maintain at least stable disease.
Time frame: Up to 2 years
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.
Time frame: 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
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.
Time frame: From the time of pre-treatment MRI to the time of death, assessed at 24 weeks
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
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.
Time frame: Up to 8 weeks
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.
Time frame: Up to 8 weeks
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.
Time frame: Up to 8 weeks
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.
Time frame: Up to 8 weeks
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.
Time frame: Up to 8 weeks
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.
Time frame: Up to 8 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Utrogestan