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Tests treatment safety and results for Posterior Fossa Ependymal Tumor
Official title Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma
ClinicalTrials.gov ID: NCT07226453
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for posterior fossa ependymal tumor.
Also referred to as Glucophage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 39
You may be able to join if
- 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...
- Participants must have adequate tumor tissue available from initial diagnosis or from pre- trial enrollment. Formalin-fixed paraffin-embedded (FFPE)...
- Participant must have measurable disease; this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be...
- Participants with an isolated local progression of the tumor following RT (or stereotactic radiosurgery, SRS) must be \> 6 months from completion of...
You likely can't join if
- Participants with a history of diabetes mellitus or those meeting criteria for pre-diabetes are excluded. Pre-diabetes is defined per American...
- Participants without any measurable disease.
- Participants who have had chemotherapy or have received radiotherapy to the non-target lesion within 3 weeks (6 weeks for nitrosoureas or mitomycin...
- Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events...
- Participants with rapidly progressive symptoms that require urgent surgery that in the investigators assessment cannot be safely deferred for 6 weeks...
- Participants who are receiving any other investigational agents.
See the full eligibility criteria
- 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.
- Participants must have adequate tumor tissue available from initial diagnosis or from pre- trial enrollment. Formalin-fixed paraffin-embedded (FFPE) material (1 full block) should be provided. If FFPE material is not...
- Participant must have measurable disease; this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be recorded) The size threshold is met if both in-plane diameters are ≥10...
- 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...
- 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.
- Prior Therapy: Participants must not be receiving metformin for other medical indications or previous exposure to metformin following their diagnosis of PFA ependymoma. However, participants treated on the TV phase, but...
- Age: 1 -39 years at the time of enrollment.
- Performance Score: Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>=50 for participants \<=16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair...
- Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
- Organ Function Requirements
- Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3.
- Platelet count \>=100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
- Serum creatinine \< 1.5 Upper Limit normal (ULN) based on age and gender
- Total bilirubin \<= 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin \< 3 x ULN or direct bilirubin \< 1.5 x ULN
- alanine aminotransferase (ALT) \<= 3 x ULN.
- aspartate aminotransferase (AST) \<=3 x ULN.
- Participants with seizure disorder may be enrolled if well controlled and are on stable dose of anti-seizure medication for \> 72 hours prior to enrollment. Participants who have neurological deficits should have...
- Participants must enroll on PNOC COMP if PNOC COMP is open to accrual at the enrolling institution.
- A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
- Participants with a history of diabetes mellitus or those meeting criteria for pre-diabetes are excluded. Pre-diabetes is defined per American Diabetes Association criteria as any of the following: fasting plasma...
- Participants without any measurable disease.
- Participants who have had chemotherapy or have received radiotherapy to the non-target lesion within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from...
- Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior...
- 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.
- Human immunodeficiency virus- (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Baltimore, Maryland, United States; Ann Arbor, Michigan, United States; St Louis, Missouri, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.