Phase 2: testing Metformin for Posterior Fossa Ependymal Tumor
This is a multi-site study of the pharmacodynamic effects and how well it works of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.
Official registry: https://clinicaltrials.gov/study/NCT07226453 · University of California, San Francisco · enrollment listed as 30
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Metformin, Planned Surgical Resection, or Magnetic Resonance Imaging (MRI). The registry lists allocation as randomized. This is a multi-site study of the pharmacodynamic effects and how well it works of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.
They plan to enroll about 30 people at 13 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Target Validation and Efficacy Study of Metformin in Patients With Recurrent or Progressive Posterior Fossa Group A (PFA) Ependymoma
Interventions: Metformin, Planned Surgical Resection, Magnetic Resonance Imaging (MRI), Specimen Collection, MR spectroscopy (MRS)
Primary outcome (registry wording): Proportion of participants with changes in biomarkers between the pre-and post-metformin treated samples (Target Validation Phase)
Who it is for (from inclusion criteria)
- Ages 1 Year to 39 Years
- Participants must have recurrent or progressive posterior fossa A (PFA) ependymoma following surgery AND radiation treatment (RT)
- Participants must have a diagnosis of PFA ependymoma. Any number of previous recurrences are permissible provided the participant meets other enrollment criteria
- Target Validation (TV) Phase:
- o Participants are candidates to undergo elective surgery for removal of all or a portion of their recurrent/progressive tumor
- Participants with an isolated local progression of the tumor following RT (or stereotactic radiosurgery, SRS) must be \> 6 months from completion of RT to the lesion to rule out pseudo progression or must have tissue confirmation of progression prior to enrollment
- Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy as outlined above
- Age: 1 -39 years at the time of enrollment
Who the registry excludes
- Participants without any measurable disease
- Participants with rapidly progressive symptoms that require urgent surgery that in the investigators assessment cannot be safely deferred for 6 weeks are excluded from target validation phase of the study
- Participants who are receiving any other investigational agents
- Concurrent radiation therapy in any form is not permitted while on the study drug
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection
- Women of childbearing potential must not be pregnant or breast-feeding
Public study contact (from the registry)
PNOC Operations Office
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
13 listed- University of Alabama at Birmingham — Birmingham, Alabama (recruiting)
- University of California, San Francisco — San Francisco, California (recruiting)
- Children's National Medical Center — Washington D.C., District of Columbia (recruiting)
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana (not_yet_recruiting)
- Johns Hopkins University — Baltimore, Maryland (recruiting)
- University of Michigan — Ann Arbor, Michigan (not_yet_recruiting)
- Washington University — St Louis, Missouri (recruiting)
- Hackensack Meridian Health — Hackensack, New Jersey (not_yet_recruiting)
- Duke University — Durham, North Carolina (recruiting)
- St. Jude Children's Research Hospital — Memphis, Tennessee (not_yet_recruiting)
- University of Utah — Salt Lake City, Utah (recruiting)
- Seattle Children's — Seattle, Washington (recruiting)
+ 1 sites outside the US on the same record
FAQ about this NCT record
Is NCT07226453 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07226453?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07226453?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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