Spots Global Cancer Trial Database for Metformin+Cytarabine for the Treatment of Relapsed/Refractory AML

Study Description

Brief Summary: The purpose of the study is to determine if metformin in combination with cytarabine is safe and effective. Participants in this research study have acute myeloid leukemia (AML) that has come back after initial treatment or has not gone away with initial therapy.There is evidence that metformin directly kills leukemia cells. Laboratory data have also shown that combinations of metformin with cytarabine are more efficient than each agent alone in killing leukemia cells in the laboratory.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of metformin (metformin hydrochloride) in combination with cytarabine in relapsed/refractory AML. II. Define the dose limiting toxicity (DLT) of metformin in combination with cytarabine in relapsed/refractory AML. SECONDARY OBJECTIVES: I. Remission rate. II. Overall survival (OS). III. Disease-free survival (DFS). IV. Length of remission. OUTLINE: This is a dose-escalation study of metformin hydrochloride in combination with Cytarabine. Patients receive metformin hydrochloride orally (PO) twice daily (BID) on days 1-15 and cytarabine intravenously (IV) over 3 hours BID on days 4-10. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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