Progesterone for Glioblastoma

This trial explores how natural progesterone might help treat glioblastoma, a type of brain cancer that has returned after treatment. Researchers aim to determine the best dose and assess whether progesterone can slow the tumor's growth and spread. Individuals with glioblastoma or gliosarcoma who have tried up to two other treatments without success may be suitable candidates for this trial. Participants will receive daily progesterone injections for up to 24 weeks, provided the treatment remains effective and side effects are manageable. As an Early Phase 1 trial, this research focuses on understanding how progesterone works in people, offering participants the opportunity to be among the first to receive this promising treatment.

The trial requires you to stop any current estrogen or progesterone therapy, including hormonal contraceptives, at least 7 days before starting the study. If you are on anti-tumor agents, you must stop them 4 weeks prior to starting the trial. Other medications are not specified, so consult with the trial team for guidance.

Research shows that progesterone might be a safe option for treating recurrent glioblastoma, a type of brain cancer. Some studies indicate that high doses of progesterone can slow the growth of cancer cells without affecting healthy cells. This suggests it could be safer than many traditional cancer treatments, which often have more severe side effects.

However, other findings are important to consider. Some studies have linked long-term use of certain progesterone-like drugs to a higher risk of developing another type of brain tumor called meningioma. This risk appears related to specific synthetic versions of progesterone, not the natural form tested in this trial.

Unlike the standard treatments for glioblastoma, which typically include surgery, radiation, and chemotherapy, therapeutic progesterone offers a unique approach by potentially targeting the hormonal pathways involved in cancer growth. Researchers are excited about this treatment because progesterone is administered subcutaneously, allowing for a steady release that may enhance its effectiveness while potentially reducing side effects. This method of delivery and the hormone-based mechanism of action present an innovative angle in the fight against this aggressive brain tumor, offering hope for improved outcomes.

Research suggests that progesterone, which participants in this trial will receive, might help treat glioblastoma by slowing tumor growth. Studies have shown that high doses of progesterone can reduce the growth of certain glioblastoma cells. It seems to work by altering how the tumor obtains energy and grows. Additionally, progesterone may accelerate the aging of tumor cells, which can help slow their spread. While these findings are promising, most of the evidence comes from lab studies, not yet from human trials.¹⁵⁶⁷⁸