Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)

This is an interventional treatment trial for Leukemia, Myeloid, Acute Read More

Inclusion Criteria:

• Patients must have a diagnosis of AML (> 20% myeloid blasts in the peripheral blood or bone marrow) or MDS with > 10% myeloid blasts in the bone marrow. Patients with Acute Promyelocytic Leukemia (APL) must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide.

• The patients must have one of the following criteria:

  • Age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities
  • Age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference
  • Age of 70 years or older with relapsed or refractory disease
• The patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy.
• Patients must have an ECOG (Zubrod) performance status of 0-2
• Patients must be able to take and tolerate oral medications
• Patients must have adequate organ function as specified in the protocol.
• Patients not on anti-coagulation must have an INR < 1.5 and a PTT within normal limits.

Exclusion Criteria:

• Pregnant women or nursing mothers are not eligible for this trial.
• Patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial.
• Patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. See protocol for listing.
• Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging
• Patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.