Using Metformin to Prevent Relapse in Bone Sarcoma Patients

Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse

This study is testing if Metformin can help prevent relapse in patients with osteosarcoma and Ewing sarcoma who are at high risk of their cancer coming back.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bologna)
• Trial ID: NCT04758000 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include non-metastatic osteosarcoma patients with tumor necrosis ≤ 60% after chemotherapy and Ewing sarcoma or osteosarcoma patients in complete remission after their first relapse.

Not a fit: Patients with metastatic disease or those with certain metabolic conditions, such as Type B diabetes, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the chances of remaining cancer-free for patients with high-risk bone sarcomas.

How similar studies have performed: While the use of Metformin in this context is novel, previous studies have shown potential benefits of Metformin in cancer treatment, suggesting a promising avenue for further exploration.

Eligibility criteria

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 this trial is running

Bologna

• 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

Conditions: Osteosarcoma, Ewing Sarcoma, Metformin, poor responders osteosarcoma, post relapse bone sarcoma