Natural Progesterone for the Treatment of Recurrent Glioblastoma
Brain & Spinal Cord Tumor
18 Years and older, Male and Female
WINSHIP5184-20 (primary)
NCI-2021-01498
STUDY00002155
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.
Eligibility
- 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)
- 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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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