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Official Title

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

Phase
Early Phase 1
Sponsor
Emory University
Enrollment
32
Timeline
Apr 2022 → Aug 2026
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Patients must have pathologic confirmation of a glioblastoma or gliosarcoma diagnosis at initial surgery or second or later surgery
  • 2Patients may have had up to two previous salvage agents administered for treatment of recurrent GBM (may be at 1st, 2nd or 3rd recurrence)
  • 3Patients must be \>= 18 years of age
  • 4Patients must be able to have magnetic resonance imaging (MRI) scans for disease follow up
  • 5Recurrent 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
  • 6White blood cell (WBC) \>= 3,000/uL (=\< 14 days prior to registration)
  • 7Absolute neutrophil count (ANC) \>= 1,500/uL (=\< 14 days prior to registration)
  • 8Platelet count of \>= 75,000/uL (=\< 14 days prior to registration)
  • 9Hemoglobin \>= 9.0 gm/dl (=\< 14 days prior to registration) (transfusion is allowed to reach minimum level)
  • 10Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) =\< 2.0 x upper limit of normal (UNL) (=\< 14 days prior to registration)
  • 11Bilirubin =\< 2 x UNL (=\< 14 days prior to registration)
  • 12Creatinine =\< 1.5 mg/dL (=\< 14 days prior to registration)
  • 13Patients must have a life expectancy of \>= 12 weeks
  • 14Patients must have a Karnofsky Performance Status (KPS) \>= 60
  • 15Patients 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
  • 16Patients must be able to understand and provide written informed consent
  • 17Both 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
  • 18Patient must not have a known allergy to progesterone
  • 19In females, no active vaginal bleeding
  • 20Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy

Exclusion Criteria

  • 1Patients 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
  • 2Patients 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
  • 3Patients with a history of severe hepatic dysfunction of disease are excluded
  • 4Patients with a history of idiopathic jaundice, severe pruritus and pemphigoid gestationis during pregnancy are excluded
  • 5Patients with a history of breast or genital tract cancer are excluded
  • 6Patients 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
  • 7Patients with an active infection or serious intercurrent medical illness are ineligible
  • 8Patients who received any other in anti-tumor agents (including investigational ones) must be off therapy for 4 weeks prior to initiating progesterone on study
  • 9Patient receiving anti-coagulation therapy are excluded
  • 10Patient with active or recent (within 6 months) thromboembolic disease are excluded
  • 11Patient with current ongoing therapy with estrogen/progesterone (including hormonal contraceptives) are excluded. Would need to stop this form of birth control at least 7 days prior to initiation of therapy to be eligible

Locations

1 site participating in this study

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Hui-Kuo G. Shu, MD, PhD, FASTRO

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →