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.
• 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