Study on Metformin for Treating Posterior Fossa Group A (PFA) Ependymoma

Sponsor: University of California, San Francisco

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07226453

Provider View

This clinical trial is exploring the effects of the drug metformin on children and young adults with a type of brain tumor called Posterior Fossa Group A (PFA) ependymoma that has returned or is getting worse.

Patient Parameters

Program Overview

The study aims to see if metformin can help stabilize or shrink tumors in patients with recurrent or progressive PFA ependymoma. It will also look at how the drug affects tumor cells and how it is processed in the body. Participants will receive metformin before surgery and may continue treatment if they have measurable disease after surgery.

Description

This study is divided into two parts: a Target Validation (TV) phase and an Efficacy phase. In the TV phase, participants will receive metformin before their planned surgery to remove the tumor. Researchers will study changes in specific proteins in the tumor cells to understand how metformin affects them. If participants still have measurable disease after surgery, they can continue to the Efficacy phase, where they will take metformin daily to see if it helps control the tumor.

The study will also explore how long participants can live without the disease getting worse and their overall survival. Researchers will measure how metformin is absorbed and distributed in the body, including in the tumor and spinal fluid. They will also use imaging techniques to study changes in the tumor's chemical profile before and after treatment.

Participants will be followed for long-term effects on their health and quality of life under a related protocol. They will continue in the study until the disease progresses or they experience unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Have a type of brain tumor called Posterior Fossa Group A (PFA) ependymoma that has come back or is getting worse after surgery and radiation.
  • Have a confirmed diagnosis of PFA ependymoma, either initially or at recurrence.
  • Have enough tumor tissue available from previous surgery for analysis.
  • Be scheduled for surgery to remove part or all of the tumor.
  • Have measurable disease after surgery, defined by specific imaging criteria.
  • Be at least 6 months from the end of radiation treatment to the tumor.
  • Not be taking metformin for other reasons or have taken it after their diagnosis.
  • Be between 1 and 39 years old.
  • Have a performance score indicating they can perform daily activities with some assistance.
  • Be on a stable or decreasing dose of corticosteroids if taking them.
  • Have adequate blood counts and organ function based on specific tests.
  • Have controlled seizures if they have a seizure disorder.
  • Be enrolled in a related study if available.
  • Be able to understand and sign a consent form, or have a guardian who can.

Exclusion Criteria

  • Have diabetes or pre-diabetes.
  • Have only non-measurable disease or isolated spread to the brain's lining.
  • Have had recent chemotherapy or radiation to non-target areas.
  • Have rapidly worsening symptoms needing urgent surgery.
  • Be taking other investigational drugs.
  • Have allergies to metformin or similar drugs.
  • Have uncontrolled illnesses or infections.
  • Be pregnant or breastfeeding.
  • Have HIV with an unstable treatment regimen or severe immune issues.

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