Using Metformin to Prevent Relapse in Bone Sarcoma Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Metformin as a maintenance therapy for patients with osteosarcoma and Ewing sarcoma who are at high risk of relapse. The study is divided into two groups: one focusing on localized osteosarcoma patients with low tumor necrosis after chemotherapy, and the other on patients in complete remission after their first relapse. Participants will receive Metformin for up to three years, with the aim of improving event-free survival rates compared to historical data. The study will evaluate the effectiveness and safety of Metformin in these high-risk populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Non metastatic osteosarcoma patients with necrosis ≤ 60 % in the end of post-operatory chemotherapy treatment (within 45 days.from the end of chemotherapy treatment).
* Osteosarcoma or Ewing sarcoma patients free from the disease after first relapse (within 45 days.from the local surgery or 45 days from the end of chemotherapy treatment).
* ≥ 14 years.
* Patient should not be participating in other clinical study.
* Patients should be able to swallow.
* Screening up to 30 days from the end of chemotherapy treatment or relapse.
* Start therapy up to 30 days from the screening.
* Normal renal function (creatinine \<1,3 mg/L, clearance creatinine ≥ 70 ml/min) end liver function (total serum bilirubina \<1,2 mg/dL, except Gilbert syndrome patients), AST e ALT \<1,8 times the normal range value

Exclusion Criteria:

* Type B diabetic patient
* Metastatic patients
* Patients with acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis).
* Patients with renal insufficiency (GFR \< 70 ml/min).
* Patients with acute conditions that could cause kidney alterations as dehydration, severe infection and shock.
* Patients with hepatic insufficiency as acute alcohol intoxication and alcoholism.
* Patients with medical conditions that could cause tissue hypoxia: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
* Patient who does not meet the inclusion criteria
* Pregnant and breastfeeding patients, or young women at childbearing age who cannot exclude the state of pregnancy (possibly excluded by serum pregnancy test (BhCG test), in accordance with the recommendations of the CTFG.

Where it's running

• Chemotherapy Div, Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Alessandra Longhi, MD — Istituto Ortopedico Rizzoli IRCSS, Bologna, Italy
• Study coordinator: Alessandra Longhi, MD
• Email: alessandra.longhi@ior.it
• Phone: +39(051)6366668

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.