Natural Progesterone for the Treatment of Recurrent Glioblastoma

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT05091866
Trial Phases:		Protocol IDs:	WINSHIP5184-20 (primary) NCI-2021-01498 STUDY00002155
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05091866

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.

Objectives

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 using the aqueous formulation of progesterone (IBSA Institut Biochimique SA, Lugano, Switzerland) given subcutaneously [Cometti 2015].
II. To determine the safety of administering daily subcutaneous natural progesterone for the treatment of patients with recurrent GBMs.
III. To determine the ORR [defined as 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.

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