Natural Progesterone for the Treatment of Recurrent Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pembrolizumab in Treating Patients With Recurrent Glioblastoma

NCT02337686

Recurrent Glioblastoma Recurrent Gliosarcoma

ACTIVE_NOT_RECRUITING PHASE2

Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme

NCT00112866

Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma +1 more

TERMINATED PHASE2

Gossypol in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

NCT00540722

Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma +1 more

COMPLETED PHASE2

Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma

NCT00036972

Brain and Central Nervous System Tumors

COMPLETED PHASE1

Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

NCT01189266

Anaplastic Astrocytoma Anaplastic Oligoastrocytoma Diffuse Intrinsic Pontine Glioma +1 more

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gliosarcoma Recurrent Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (progesterone)

Patients receive progesterone SC QD for up to 24 weeks in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Therapeutic Progesterone

Intervention Type BIOLOGICAL

Given SC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Therapeutic Progesterone

Given SC

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Quality of Life Assessment Corlutina Corluvite Corpus luteum hormone Cyclogest Gestiron Gestone Lipo-Lutin Luteohormone Lutocyclin Lutocylin M Lutogyl Lutromone Progestasert Progesterone Progestin Progestogel Progestol Progeston Prolidon Proluton Syngesterone Utrogestan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Patients 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
* Patients 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
* Patients with a history of severe hepatic dysfunction of disease are excluded
* Patients with a history of idiopathic jaundice, severe pruritus and pemphigoid gestationis during pregnancy are excluded
* Patients with a history of breast or genital tract cancer are excluded
* Patients 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
* Patients with an active infection or serious intercurrent medical illness are ineligible
* Patients who received any other in anti-tumor agents (including investigational ones) must be off therapy for 4 weeks prior to initiating progesterone on study
* Patient receiving anti-coagulation therapy are excluded
* Patient with active or recent (within 6 months) thromboembolic disease are excluded
* Patient 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No