Clinical Trial NU 11H03
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- Principal Investigator
- Jessica Altman
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 11H03
- The purpose of the clinical part 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.This research study involves testing an investigational drug called metformin in combination with a standard treatment for relapsed refractory AML called cytarabine. An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for use in the United States for this indication. Metformin is approved by the FDA for the treatment of diabetes. There is evidence to that metformin directly kills leukemia cells. Data from our laboratory have also shown that combinations of metformin with cytarabine are more efficient than each agent alone in killing leukemia cells in the laboratory.
Some of the eligibility criteria include:
- Participants must be at least 18 years of age.
- Participants must have relapsed after first complete remission or failed to respond to 1 or more cycles of daunorubicin and cytarabine.
- Participants who have diabetes that has been treated with metformin for are not eligible for this study.
- Participants must have acute myeloid leukemia.
- Description of Treatment
- Participants will have an IV inserted (a PICC line), that can stay in place for weeks or months without being replaced. Participants will receive cytarabine chemotherapy through the vein for 6 days. 3 days prior to starting the cytarabine chemotherapy, participants will take a dose of metformin by mouth twice a day for a total of 15 days. Approximately 12-14 days after starting the cytarabine chemotherapy, participants will have a repeated procedure to remove bone marrow, fluid and cells from inside the bone, to assess the response to the treatment.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
- A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
last updated: 03-Oct-15 11:59 PM
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