Patients who agree to participate in this trial will be screened for the FLT 3 mutation by bone marrow exam. They will have a physical exam, blood test, EKG, chest x-ray, bone marrow aspirate and a pregnancy test. Patients will be required to have weekly blood test and bone marrow aspirate monthly.

Condition	Treatment or Intervention	Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes	Drug: PKC412, an inhibitor of FLT3	Phase II

Further Study Details: 

Expected Total Enrollment:  24

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

• Patients: with AML who are not candidates for myelosuppressive chemotherapy or with AML who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with MDS subtypes RAEB, RAEB-T or CMML.
• Who 0-2
• FLT 3 mutation
• AML (MDS patients exempted) must have a total WBC (including blast) of > 5,000
• Patients must have a serum creatinine of < 1.5 x ULN, SGOT/SGPT < 3 x ULN and total bilirubin < 2.0 x ULN. No active infections; no pulmonary infiltrates on CXR know to be new within 4 weeks.

California
      UCLA Medical Center, Los Angeles,  California,  90095,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  United States
New York
      Memorial Sloan Kettering Cancer Center, New York City,  New York,  United States
      New York Weill Cornell Medical Center, New York,  New York,  10021,  United States

Study ID Numbers:  PKC412 2104
Record last reviewed:  November 2004
Last Updated:  November 16, 2004
Record first received:  September 16, 2002
ClinicalTrials.gov Identifier:  NCT00045942
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08