NCT05091866

Natural Progesterone for the Treatment of Recurrent Glioblastoma

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gliosarcoma
• Recurrent Glioblastoma

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
BIOLOGICAL	Therapeutic Progesterone	Given SC

Timeline

• Start date: 2022-04-11
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2021-10-25
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study