Feasibility of CPI-613 for Acute Myeloid Lekumia

What we are studying

Phase II studies are an early step in testing an investigational medication in humans. These studies look to see how many people complete the planned therapy and which of them has a response. It is the first step to determine if the experimental therapy can be tested in a larger trial. The purpose of this study is to test whether the combination of an investigational drug called CPI-613 (“study drug”) given with two other chemotherapy drugs: cytarabine and mitoxantrone is effective in controlling your leukemia and how many patients complete all planned therapy. CPI-613 is thought to kill cancer cells by turning off their mitochondria. Mitochondria are used by cancer cells to produce energy and are the building blocks needed to make more cancer cells. By shutting off these mitochondria, CPI-613 deprives the cancer cells of energy and other supplies that they need to survive and grow in your body. We want to find out what effects, good and/or bad, CPI-613 has on you and your cancer when given along with cytarabine and mitoxantrone. We also want to see if CPI-613 when given alone as a maintenance therapy can prolong remission for those patients who respond to this treatment. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). CPI-613 is an investigational drug that has not been approved by the FDA for any type of tumor or cancer, and it is currently being studied for the treatment of cancer.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Documented relapsed and/or refractory Acute Myeloid Leukemia or granulocytic sarcoma
  • 18 or older
  • Expected more than 3 month survival
  • No radiotherapy treatment with cytotoxic agents biologic agents or ant-cancer therapy
  • Practice contraceptive methods during study
  • Adequate hepatic function
  • Adequate renal function
  • Adequate coagulation
  • Eft Ventricular Ejection Fraction sufficient to safely administer mitoxantrone as determined by the treating physician

What is involved

  • This clinical research study consists of several parts induction
  • Consolidation and maintenance.

Compensation

Parking will be validated for study-related visits.

Contact Information

Study Coordinator
Mark Holt
Email
dmholt@wakehealth.edu
Phone
336- 713-7035
Principal Investigator
Timothy S. Pardee

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.