AzTrials
AzTrials

GliosarcomaEarly Phase 1NCT05091866

Natural Progesterone for the Treatment of Recurrent Glioblastoma

A Early Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Therapeutic Progesterone in people with Gliosarcoma and Recurrent Glioblastoma, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gliosarcoma, Recurrent Glioblastoma
What is being tested?
Quality-of-Life Assessment, Questionnaire Administration and Therapeutic Progesterone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
11 Apr 2022to 9 Mar 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologic confirmation of a glioblastoma or gliosarcoma diagnosis at initial surgery or second or later surgery
  • Patients may have had up to two previous salvage agents administered for treatment of recurrent GBM (may be at 1st, 2nd or 3rd recurrence)
  • Patients must be >= 18 years of age
  • Patients must be able to have magnetic resonance imaging (MRI) scans for disease follow up
  • Recurrent GBM must consist of a minimum of 1 cm^3 of contrast enhancing disease on high resolution T1 post-contrast sequence as defined on pre-treatment MRI obtained within 14 days of initiating therapy
  • White blood cell (WBC) >= 3,000/uL (=< 14 days prior to registration)
Show all 20Show fewer
  • Absolute neutrophil count (ANC) >= 1,500/uL (=< 14 days prior to registration)
  • Platelet count of >= 75,000/uL (=< 14 days prior to registration)
  • Hemoglobin >= 9.0 gm/dl (=< 14 days prior to registration) (transfusion is allowed to reach minimum level)
  • Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) =< 2.0 x upper limit of normal (UNL) (=< 14 days prior to registration)
  • Bilirubin =< 2 x UNL (=< 14 days prior to registration)
  • Creatinine =< 1.5 mg/dL (=< 14 days prior to registration)
  • Patients must have a life expectancy of >= 12 weeks
  • Patients must have a Karnofsky Performance Status (KPS) >= 60
  • Patients who are women of childbearing potential must have a negative pregnancy test documented =< 14 days prior to registration and agree to use adequate barrier contraceptive methods or abstinence for duration of study
  • Patients must be able to understand and provide written informed consent
  • Both men and women, and members of all races and ethnic groups are eligible for this trial. Subjects will be approximately representative of the demographics of the referral base for the participating institutions
  • Patient must not have a known allergy to progesterone
  • In females, no active vaginal bleeding
  • Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy

Who cannot join

  • Patients with pacemakers, aneurysm clips, neurostimulators, cochlear implants, metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded
  • Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are excluded
  • Patients with a history of severe hepatic dysfunction of disease are excluded
  • Patients with a history of idiopathic jaundice, severe pruritus and pemphigoid gestationis during pregnancy are excluded
  • Patients with a history of breast or genital tract cancer are excluded
  • Patients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off all therapy for that disease for >= 3 years, are ineligible
Show all 11Show fewer
  • Patients with an active infection or serious intercurrent medical illness are ineligible
  • Patients who received any other in anti-tumor agents (including investigational ones) must be off therapy for 4 weeks prior to initiating progesterone on study
  • Patient receiving anti-coagulation therapy are excluded
  • Patient with active or recent (within 6 months) thromboembolic disease are excluded
  • Patient with current ongoing therapy with estrogen/progesterone (including hormonal contraceptives) are excluded. Would need to stop this form of birth control at least 7 days prior to initiation of therapy to be eligible

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Pilot Study of Subcutaneously Administered Natural Progesterone for the Treatment of Recurrent GBM

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Quality-of-Life Assessment, Questionnaire Administration, Therapeutic Progesterone
Medical subject headings
Gliosarcoma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Therapeutic ProgesteroneBiological

    Also called Corlutina, Corluvite, Corpus luteum hormone, Cyclogest

    Given SC

Study groups in NCT05091866
Study groupRoleWhat they receive
Treatment (progesterone)ExperimentalPatients receive progesterone SC QD for up to 24 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Therapeutic Progesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: Up to 2 years

  3. Overall response rate

    Will be looking for the fraction of patients that are able to maintain at least stable disease.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. 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.

    Measured: 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

  2. 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.

    Measured: From the time of pre-treatment MRI to the time of death, assessed at 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start11 Apr 2022
  3. Primary completion20 Dec 2024
  4. Study completion9 Mar 2026

Why it stopped: Review of Drug Supply

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05091866
Sponsor's protocol ID
STUDY00002155
Other IDs
NCI-2021-01498, WINSHIP5184-20, P30CA138292
Status last verified
Apr 2026
First submitted
14 Sep 2021
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Therapeutic Progesterone in people with Gliosarcoma and Recurrent Glioblastoma, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Review of Drug Supply). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Natural progesterone blood levels (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05091866.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in