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Natural Progesterone for the Treatment of Recurrent Glioblastoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGEARLY_PHASE1

Natural Progesterone for the Treatment of Recurrent Glioblastoma

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

NCT05091866•Emory University

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)
•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)
+10 more criteria

Exclusion Criteria

•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
•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
+1 more criteria

Locations (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Key Dates

Start Date

April 11, 2022

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2027

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

GliosarcomaRecurrent Glioblastoma

Interventions

Quality-of-Life Assessment

OTHER

Questionnaire Administration

OTHER

Therapeutic Progesterone

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Natural Progesterone for the Treatment of Recurrent Glioblastoma

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

Study of Pembrolizumab and M032 (NSC 733972)

Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM

A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma